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 2017-04-27 for DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG 382805 manufactured by Teleflex Medical.
[73908491]
(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 investigation report has not been submitted at this time. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[73908492]
The elastic broke in 2 pieces during use. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[78991797]
(b)(4). The customer returned one unit of 382805 dermahook 1/2 hook pkg/bx 6 hks/pkg for investigation. One thermoplastic elastomeric (tpe) band was returned with the hook and suture. The returned sample was visually examined with and without magnification. Visual examination revealed that the tpe band was broken at what appears to be approximately the location where the suture was tied to the band. The suture thread and hook were still attached to each other but not to the band. If the suture knot is tied too tight, this can cause a breakage in the tpe band due to the excess tension that is applied. The returned sample appears used as there is biological material present on the device. A functional test was conducted on the returned sample. The band was able to be stretched up to six times its length without snapping. 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 0. 17 lb-force without breaking. " by being able to be stretched up to six times its length without breaking, the band meets the requirement. Since the suture was not returned attached to the tpe band, it could not be confirmed whether or not the suture was tied too tightly to the band. However , the break point is 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 0. 17 lb-force without breaking. " the ifu for this product, 220002750, 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 upon the sample received. One tpe band was returned that was broken at approximately the point at which the suture would be tied to the band. The hook and suture were also returned, but they were not attached to the band. Functional testing was performed and it was found that the returned band was able to stretch up to six times its original length without 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
[78991798]
The elastic broke in 2 pieces during use. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2017-00414 |
| MDR Report Key | 6526801 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-04-27 |
| Date of Report | 2017-04-04 |
| Date of Event | 2017-03-31 |
| Date Mfgr Received | 2017-05-31 |
| Device Manufacturer Date | 2016-09-20 |
| Date Added to Maude | 2017-04-27 |
| 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 | 2017-04-27 |
| 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 | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-27 |