MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 105MM; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.038.105S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight, ethnicity and were not provided for reporting.Implant date: unknown.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 were 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 device report: nail extractor (part# 03.037.032, lot# 987983, quantity 1) insertion handle (part# unknown, lot# unknown, quantity# 1).Unknown tfna nail (part# unknown, lot# unknown, quantity# 1).This report is for one (1) tfna screw 105 mm.This is report 3 of 3 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.H10 additional narrative: concomitant devices updated.Date returned to manufacturer dhr review was completed.Part mfg date: 09-jul-2015, part exp.Date: n/a , manufacturing location: (b)(4), lot number: 9848053, part number: 04.038.105.Dhr record review: a review of the device history record (dhr) revealed no non-conformances.The dhr shows lot# 9848053 of tfn screw 105mm was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material dhr revealed this lot met all specifications with no non-conformances or rework noted.Customer quality conducted an investigation of the returned device.Complaint summary: during a removal surgery, the tfna screw peeled off.Flow: damaged: visual (appearance not as expected) visual inspection: the tfna screw (part 04.038.105, lot 9848053, mfg 09-jul-2015) was received at us cq with a crack radiating around the circumference screw at the most proximal point of the interior threads.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional inspection dimensional analysis was not performed as relevant features are significantly deformed through post manufacturing damage.Document/specification review the following drawing(s) was reviewed; --ti tfna screw: dhr review showed no ncr¿s were generated during production.The material, and material properties of the returned part were determined to be conforming at the time of manufacture based on review of the dhr.Conclusion: the complaint condition is confirmed as the tfna screw (part 04.038.105, lot 9848053) was received cracked.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it likely that excessive forces were applied in order to extract the screw, causing the material to crack.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
Concomitant devices report: insertion handle (part number unknown, lot number unknown, quantity 1).This report is for one (1) tfna screw 105mm.This is report 3 of 5 for (b)(4).

• Brand Name: TFNA SCREW 105MM
• 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: 7763966
• Report Number: 2939274-2018-53245
• Device Sequence Number: 11033988
• Product Code: HSB
• UDI-Device Identifier: 10886982098535
• UDI-Public: (01)10886982098535
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• 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,Followup
• 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 Model Number: 04.038.105S
• Device Catalogue Number: 04.038.105
• Device Lot Number: 9848053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 08/17/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE DESCRIPTION; SEE EVENT DESCRIPTION
• Patient Age: 33 YR