MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11/130 DEG TI CANN TFNA 170 - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.142S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j sales representative.The investigation could not be completed.No conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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, after placing lag screw for trochanteric fixation nail-advanced (tfna), the surgeon attempted to lock lag screw in for rotational stability using the flexible hex driver and was unable to lock it down.Surgeon removed nail and lag screw and used a new nail.The surgery was delayed for ten (10) minutes.The procedure was successfully completed.This report is for one (1) 11mm/130 deg ti cann tfna 170mm - sterile.This is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: a product investigation was conducted.Visual inspection: the 11/130 deg ti cann tfna 170 - sterile (04.037.142s, lot #: 56p5532) was returned and received at us cq.Upon visual inspection, it was observed that the lock prong assembly was broken inside the helical blade hole.Deformation was observed on the inner surface of the helical blade hole.No other issues were observed with the returned device.Functional test: a functional test was not performed as the femoral nail was returned by itself.But the broken lock prong assembly could have caused the complaint condition.The complaint was unable to be replicated with the returned device.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Investigation conclusion: the complaint condition was confirmed for the 11/130 deg ti cann tfna 170 - sterile (04.037.142s, lot #: 56p5532).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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, h6: a device history record (dhr) review was conducted: manufacturing location: monument.Manufacturing date: 27-may-2020.Expiration date: 30-apr-2030.Part number: 04.037.142s, 11mm/130 deg ti cann tfna 170mm-sterile.Lot number: 56p5532 (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 all components issued met current defined requirements.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: component parts were not reviewed as the reported complaint condition of ¿unable to lock down head element using flexible hex driver¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.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: 11/130 DEG TI CANN TFNA 170 - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11697284
• Report Number: 2939274-2021-01971
• Device Sequence Number: 3084729
• Product Code: HSB
• UDI-Device Identifier: 10886982096548
• UDI-Public: (01)10886982096548
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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: 04.037.142S
• Device Catalogue Number: 04.037.142S
• Device Lot Number: 56P5532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/25/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAIL HEAD ELEM: TFNA LAG SCREW; UNK - SCREWS: LOCKING; UNK SCREWDRIVER
• Patient Age: 70 YR