MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14MM/130 DEG TI CANN TFNA 400MM/LEFT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.461S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter is a j & j employee.(b)(4).The device was received, the investigation is in progress, 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 an unknown date, the patient underwent a removal of a broken tfna hip nail that broke inside the patient.The procedure outcome and patient status is unknown.Concomitant device reported: unknown helical blade (part # unknown, lot # unknown, quantity 1), unknown locking screw (part # unknown, lot # unknown, quantity unknown).This report is for one (1) 14mm/130 deg ti cann tfna 400mm/left-sterile.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.The 14mm/130 deg ti cann tfna 400mm/left-sterile(p/n: 04.037.461s & lot #: h382833 ) was returned and received at us cq.Upon visual inspection, it was observed that the device was broken through the walls of the helical blade opening of the nail.A drill mark was noted to the device.There were scratches on the device which have no impact on the device functionality.No other issues were identified with the returned device.The complaint condition of broken was confirmed for the 14mm/130 deg ti cann tfna 400mm/left-sterile(p/n: 04.037.461s & lot #: h382833 ).There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.Pie was launched previous to this complaint to investigate tfna nail breakage and associated drill marks/damage at the head element hole/blade aperture.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot manufacturing location: monument.Manufacturing date: 14-jun-2017.Expiration date: 31-may-2027.Part number: 04.037.461s, 14mm/130 deg ti cann tfna 400mm/left-sterile.Lot number: h382833 (sterile).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: 04.037.912.4, wave spring, shim ended, bp55.Lot number: h249497.Part number: 04.037.942.2, lock prong, 130 degree tfna, bp55.Lot number: l443329.Part number: 04.037.912.3, tfna lock drive, bp58.Lot number: h367328.Part number: 21127, timoagri16.00, bp80.Lot number: h212821.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.

• Brand Name: 14MM/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: 10516466
• Report Number: 2939274-2020-04081
• Device Sequence Number: 3316648
• Product Code: HSB
• UDI-Device Identifier: 10886982097651
• UDI-Public: (01)10886982097651
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

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: Health Professional
• Device Model Number: 04.037.461S
• Device Catalogue Number: 04.037.461S
• Device Lot Number: H382833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 10/01/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention