MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-04-04 for DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG 382805 manufactured by Teleflex Medical.
[71627490]
(b)(4). The device history review for the product dermahook 1/2 hook 10 pkg/bx 6 hks/pkg, lot #73j1600588 investigation did not show issues related to the complaint. The device has not been returned for investigation at this time. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[71627491]
The dermahook elastic broke when being used as a retractor in surgery. The break added 5 minutes to the procedure time. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[74944999]
(b)(4). The customer returned three partial derma hooks. Three broken thermoplastic elastomeric (tpe) bands, two sutures, and one suture/hook were returned. Two hooks were missing. The returned samples were visually examined with and without magnification. Visual examination revealed that one of the returned bands had a clean break and a partial tear, another band had two breaks, and the final band had three breaks. All three bands were broken at what appears to be approximately at the point at which the suture was tied to the band. If the suture is tied too tight, this can cause the breakage in the tpe band due to the excess tension that is applied. The samples appear used as there is biological material present on the returned samples. Reference files (b)(4) for investigation photos. A functional test was conducted on all three of the returned tpe bands. The first band that only had 1 break was able to stretch to approximately three times its length before it snapped at the partial tear. The band was stretched again and this time, the band was able to be stretched more than four times its length without snapping. Next, the second band that had two breaks was tested. The band was able to be stretched over four times its original length before it snapped. Finally, the third band other remarks: was tested. All three pieces of the band were tested and able to stretch to over four times its length. One small piece of the band snapped, but the other two pieces of the band did not snap when stretched to four times its original length. According to dhf d001915 rev. 03, "the band shall be able to stretch at least triple or 300% its original length with a force of 0. 90 lb 0. 17 lb-force without breaking. " all of the returned bands were able to be stretched to at least four times its original length before breaking. Since the tpe bands were not returned with the sutures attached, it could not be confirmed whether or not the sutures were tied too tightly to the bands. However, one of the break points on each band was consistent with damage found when the suture is tied too tight. This could be caused by applying too much force on the suture so that the band starts to bulge out of the suture and eventually snap. Specifications per graphic 14-2-001470 rev. 01 and the dhf for this product, d001915 rev. 03, were reviewed as a part of this complaint investigation. According to dhf d001915 rev. 03, "the band shall be able to stretch at least triple or 300% its original length with a force of 0. 90 lb 0. 17 lb-force without breaking. " the ifu for this product, (b)(4), was also reviewed as a part of this complaint investigation. The ifu for this product states, "if the elastic band contains tears, splits or other damage, do not use. Do not overstretch the elastic band. " a corrective action is not required at this time. The device history record review showed no evidence to suggest a manufacturing related cause. Based on the condition of the samples received and the time of discovery, operational context caused or contributed to this event. The reported complaint of "broken" was confirmed based on the sample received. Three broken tpe bands , two suture threads, and one suture/hook were returned. The broken bands were returned broken at approximately the point at which the suture would be tied to the band. Functional testing was performed and it was found that each of the returned bands were able to stretch at least four times its original length before breaking which meets the requirement of being able to stretch three times its length. A device history record review was performed on the device with no evidence to suggest a manufacturing related cause. Based on the condition of the samples received and the time of discovery, operational context caused or contributed to this event. No further action will be taken.
Patient Sequence No: 1, Text Type: N, H10
[74945000]
The dermahook elastic broke when being used as a retractor in surgery. The break added 5 minutes to the procedure time. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2017-00245 |
| MDR Report Key | 6456815 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-04-04 |
| Date of Report | 2017-03-16 |
| Date of Event | 2017-03-14 |
| Date Mfgr Received | 2017-05-11 |
| Device Manufacturer Date | 2016-09-20 |
| Date Added to Maude | 2017-04-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG |
| Generic Name | INSTRUMENT,SURGICAL,NON-POWERED |
| Product Code | HAO |
| Date Received | 2017-04-04 |
| Returned To Mfg | 2017-04-19 |
| Catalog Number | 382805 |
| Lot Number | 73J1600588 |
| Device Expiration Date | 2018-03-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-04 |