MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 11MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.145S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).Date of device breakage is (b)(6) 2018, exact date is not known.Date of implant reported as (b)(6) 2017, exact date is not known.A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.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.
Event or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported patient was implanted with a trochanteric fixation nail advanced (tfna) nail, helical blade, and locking screw in (b)(6) 2017.Patient underwent a revision of the tfna helical blade in (b)(6) 2018 as it was too long.At the same time, the distal locking screw broke but was left implanted.It was reported that at the end of (b)(6) 2018, the tfna nail broke.Patient was returned to surgery on (b)(6) 2018 and revised to a hip prosthesis.Patient status reported as good.The revision of the tfna helical blade in (b)(6) 2018 is addressed in (b)(4).This report addresses the revision due to broken nail.Concomitant devices reported: tfna fenestrated helical blade 85mm (04.038.385s, lot h554890, quantity 1), 5.0mm locking screw with t25 stardrive 36mm for im nails (04.005.526, lot l732033, quantity 1).This report is for one (1) 11mm 130 degree cannulated tfna nail 235mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Dhr review was completed.Manufacturing location: monument, manufacturing date: 25-oct-2017, expiration date: 01-oct-2027, part number: 04.037.145s, 11mm/130 deg ti cann tfna 235mm/left- sterile, lot number: h483880 (sterile).Lot quantity (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process/inspect dimensional/final met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label log lppf, was reviewed and determined to be conforming.Scn 14265 supplied by (b)(4) was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component parts reviewed: 04.037.942.2, lock prong, 130 degree, tfna, bp55 lot number: l558030, lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.04.037.912.4, wave spring, shim ended, bp55 lot number: h316275 lot quantity:(b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card received from smalley dated 28-jun-2017 were reviewed and determined to be conforming.04.037.912.3, tfna lock drive, bp58 lot number: h463145, lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, met all inspection acceptance criteria.21127, timoagri16.00, bp80 lot number: h282099, lot quantity: (b)(4).Certificate of test received from ati specialty materials dated 14-dec-2016 was reviewed and determined to be conforming.Lot summary report dated 23-jan-2017 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.Customer quality conducted an investigation of the returned device.Customer quality investigation: investigation flow: broken: device condition: visual inspection performed at customer quality (cq) observed broken at the lag screw mating region.The broken portion was returned.No new issues were identified.The lag screw was also returned with the given broken nail.Furthermore, per complaint description it was identified that even the distal screw was broken.The broken screw will be investigated under (b)(4).The given complaint condition agrees with the returned device condition and therefore the complaint was confirmed.Dimensional analysis and document/specification review: relevant drawings for the returned instrument were reviewed (both from the time of manufacture and present revision) were reviewed and no design issues were identified.Ti cannulated trochanteric fixation nail, dimensional analysis was not performed on relevant broken portions due to significant post manufacture damage.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Furthermore, the raw material reviewed, was confirmed to meet the specification with no (relevant) non-conformance noted.Therefore, no manufacturing related issues including any possible issues pertaining to device material were identified during the investigation.Furthermore, the tfna dcrm document reviewed during investigation completely addressed the complaint condition.A definitive root cause could not be determined based on the provided information.However, the failure mode is typically associated with unintended excessive loading during post-op activities with incorrect choice of implant size.Conclusion: the overall complaint condition was confirmed; however, no product design issues or manufacturing discrepancies were identified during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

• Brand Name: 11MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7800761
• Report Number: 8030965-2018-55837
• Device Sequence Number: 2488931
• Product Code: HSB
• UDI-Device Identifier: 10886982096579
• UDI-Public: (01)10886982096579
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 04.037.145S
• Device Catalogue Number: 04.037.145S
• Device Lot Number: H483880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 09/30/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Weight: 55