MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.161S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dhr review was completed.Manufacturing location: (b)(4) manufacturing date: 14-aug-2015 expiration date: 31-jul-2025 part #: 04.037.161s, 11mm/130 deg ti cann tfna 400mm / left - sterile.Lot number: 9876630 (sterile) lot quantity: 6 work order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final, met all inspection acceptance criteria.Inspection sheet, tfna assembly instruction, met all inspection acceptance criteria.Packaging label log was reviewed and found to be conforming.Packaging bom indicates that all packaging used met current specifications.(b)(4) supplied by (b)(4) was reviewed and found to be conforming.This lot met all dimensional, visual, sterilization 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: part number: 04.037.942.2 - lock prong, 130 degree, tfna bp-55 lot number: 9375370 lot quantity: 96 purchased finished goods traveler met all inspection acceptance criteria.Part number: 04.037.912.4 - wave spring, shim ended bp-55 lot number: 7921038 lot quantity: 995 work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Material certification and certificate of conformance and quality history card supplied by (b)(4) dated (b)(4) 2015 was reviewed and found to be conforming.Part number: 04.037.912.3 - tfna lock drive bp-58 lot number: 9852387 lot quantity: 80 work order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part number: 21127 ¿ timoagri16.00 bp-80 lot number: 7853398 certified test report received from (b)(4) dated (b)(4) 2014 was reviewed and found to be conforming.Certificate of test received from howmet castings dated (b)(4) 2014 was reviewed and found to be conforming.Lot summary report dated (b)(4) 2014 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Customer quality conducted an investigation of the returned device.Complaint summary: there were multiple devices with issues in this complaint.Initially, the nail was reported as a concomitant device however during the investigation it was noted that the threads were deformed.The flow for broken was selected to complete this investigation.Flow: broken visual inspection: the nail (part 04.037.161s, lot 9876630, mfg 14-aug-2015) was received at us cq with a broken tang.The fracture is at the transition between body of the nail and proximal tang.There was no initial complaint against this device, the sales consultant reported the device as concomitant however on inspection at us cq it was noticed that the tang was broken, therefor the complaint is confirmed.Dimensional inspection dimensional analysis could not be completed as the tang was broken off and not returned.Document/specification review the following drawing(s) was reviewed: tabulated tfna, 11mm ti tfna.Dhr review showed no ncr¿s were generated during production.Raw material receiving/putaway checklist met all inspection acceptance criteria.Conclusion: the complaint condition is confirmed as the nail (part 04.037.161s, lot 9876630) was received broken.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces during removal.No new malfunctions were observed during the course of 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.
Event or Problem Description
It was reported that upon opening the set during a trochanteric fixation nail advance (tfna) removal on (b)(6) 2018, the tip of the helical blade/screw extractor was discovered to be broken off and could not be used to remove the (tfna) screw.The insertion handle was then connected with the helical blade/screw coupling screw to the (tfna) screw in an attempt to remove the (tfna) screw.The screw was finally removed, but the screw inserter, coupling screw, and (tfna) screw were all damaged in the process.The helical blade/screw coupling screw won't slide in, the screw inserter was bent and the tfna screw peeled off.It was unknown when the hardware was implanted.The hardware removal was scheduled due to the patient's age.There was a 15 minute surgical delay.The surgery was successfully completed.Concomitant devices report: insertion handle (part number unknown, lot number unknown, quantity 1) this report is for one (1) 11mm 130 degree cannulated tfna nail 400mm left this is report 5 of 5 for (b)(4).

• Brand Name: 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7794309
• Report Number: 2939274-2018-53367
• Device Sequence Number: 16442907
• Product Code: HSB
• UDI-Device Identifier: 10886982096692
• UDI-Public: (01)10886982096692
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: 04.037.161S
• Device Catalogue Number: 04.037.161S
• Device Lot Number: 9876630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 08/17/2018
• Patient Sequence Number: 1
• Patient Age: 33 YR