MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-04-30 for IN SITU BENDER-RIGHT 388.112 manufactured by Synthes Tuttlingen.
[16183164]
It was reported that during an initial t2-l1 posterior fusion surgery the in-situ rod bender-right broke. It was reported the patient had scoliosis and had hard bones. After placing the rod and loading all the caps, the surgeon began using the rod bender, he bent the rod in a couple of areas but the bender snapped on the last area that he wanted to bend. A single broken shard was generated that was successfully retrieved from the patient and placed alongside the instrument at the back table. The surgery continued and the surgeon was happy with how the rod looked despite the broken instrument. There was no harm to the patient and surgery was delayed by two to three minutes. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[16390195]
Device was used for treatment, not diagnosis. No patient information reported. Additional product code: hwx. Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. Device history records was conducted. The report indicates that there were no issues during the manufacture of the product that would contribute to this complaint condition. The raw material which was delivered as lot #00057650 is corresponding to the specifications. The hardness was measured at the time of the manufacturing at 46,9 hrc and was found to be good. No ncrs were generated during production. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[34397872]
Device is an instrument and is not implanted/explanted. A product investigation was completed: one in situ rod bender (388. 112, lot t969971) was returned with a complaint condition of a broken jaw on the straight end of the instrument. The complaint condition was confirmed after examination as an 11mm fragment broke off the jaw. A definitive root cause was unable to be determined; however the failure is consistent with the application of excessive force to the instrument (manufactured september 2011). Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. The raw material is corresponding to the specifications. The hardness was measured at the time of the manufacturing and was found to be good. No non-conformance reports were generated during production. The returned instrument was examined and the complaint condition was able to be confirmed. The material at the fracture site appears to be homogenous without signs of fatigue. The failure mode is consistent with a mechanical overload. The complaint is confirmed. Per the technique guides, the benders are included in uss, pangea, and click? X systems for in situ sagittal plane bending of rods. Alternatively, rod benders 388. 91, 388. 92, 388. 112, 388. 113, 388. 117, 388. 961, 03. 620. 020, 03. 622. 060, 03. 622. 061, and 03. 622. 062 may be used to achieve contouring of the rods. Relevant drawings for the returned instrument were reviewed, both current and from the time of manufacturing. The bender is made from h900 heat treated 17-4ph and is appropriate for the intended use of the instruments as h900 provides maximum hardness. Wear coupled with user technique may have caused the complaint condition however the user technique is unknown and so the root cause is indeterminate. The design, materials and finishing processes were found to be appropriate for the intended use of these devices. A definitive root cause was unable to be determined; however the failure is consistent with the application of excessive force to the instrument. The calculated occurrence rate is acceptable under the system risk assessment. Additionally no design deficiencies were identified which would contribute to the complaint condition. Patient was involved but patient id is unknown device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680938-2015-10039 |
| MDR Report Key | 4740989 |
| Report Source | 05,07 |
| Date Received | 2015-04-30 |
| Date of Report | 2015-04-14 |
| Date of Event | 2015-04-14 |
| Date Mfgr Received | 2015-06-12 |
| Device Manufacturer Date | 2011-09-07 |
| Date Added to Maude | 2015-04-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IN SITU BENDER-RIGHT |
| Generic Name | INSTRUMENT, BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2015-04-30 |
| Returned To Mfg | 2015-04-17 |
| Catalog Number | 388.112 |
| Lot Number | T969971 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES TUTTLINGEN |
| Manufacturer Address | UNTER HASSLEN 5 TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-30 |