MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12/125 DEG TI CANN TFNA 170 - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.212S
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Reporter is a j&j sales representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 on (b)(6) 2021, the unknown screw sheared off and would not allow to be locked to the nail.It was unknown if there was a surgical delay.The procedure outcome was unknown.There was no adverse event to the patient.Concomitant device reported: proximal femoral nailing system (tfna) nail (part# 04.037.212s, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for (1) 12/125 deg ti cann tfna 170 - sterile.This report is 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.H3, h6: a product investigation was conducted.Visual inspection: the 12/125 deg ti cann tfna 170 - sterile (p/n: 04.037.212s, lot number: 89p9461) was received at us cq.Visual inspection of the complaint device showed the distal tip of the locking prong subcomponent had broken off.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: relevant drawing was reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the distal tip of the locking prong subcomponent had broken off.The locking prong breaking would cause the locking prong to be unable to lock.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: manufacturing location: monument, manufacturing date: 19-feb-2021, expiration date: 31-jan-2031, part number: 04.037.212s, 12mm/125 deg ti cann tfna 170mm - sterile, lot number: 89p9461 (sterile), lot quantity: (b)(4).Production 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 (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 04.037.912.3, tfna lock drive lot number: 81p0796, lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended lot number: 70p1951 lot quantity: (b)(4).Production 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 were reviewed and determined to be conforming.Part number: 04.037.912.2, lock prong, 125 degree, tfna lot number: 67p7196 lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Part number: 21127, timoagri16.00 lot number: 56p1212 lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Certified test report was reviewed and determined to be conforming.Lot summary report met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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
Updated event description: it was reported that on (b)(6) 2021, the internal set screw sheared off and would not allow the screw to locked to the nail.The nail was removed from patient and an identical new nail was opened to compete surgery.There was a five (5) minutes surgical delay.The procedure was successfully completed.There was no adverse event to the patient.This is report 1 of 2 for (b)(4).

• Brand Name: 12/125 DEG TI CANN TFNA 170 - 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: 11921566
• Report Number: 2939274-2021-02728
• Device Sequence Number: 3269096
• Product Code: HSB
• UDI-Device Identifier: 10886982097026
• UDI-Public: (01)10886982097026
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: 04.037.212S
• Device Catalogue Number: 04.037.212S
• Device Lot Number: 89P9461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 06/24/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING