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

Model Number	04.037.160S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).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 a patient was implanted with trochanteric fixation nail-advanced (tfna) on an unknown date in (b)(6) 2021.Tfna nail broke post-operatively at the junction of the nail and the lag screw.The revision procedure was performed on (b)(6) 2021 with removal of tfna and insertion of trochanteric fixation nail (tfn).Patient outcome is unknown.This report is for one (1) 11mm/130 deg ti cann tfna 400mm/right - 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6 - codes updated to imdrf codes.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the image attached in the email in notes & attachments section of pc titled "additional information from kenny koay".The image was reviewed and the complaint condition is confirmed.The tfna nail appears to be broken into two pieces at the junction between the nail and the helical screw.There does not appear to be any other visual defects or damage that would contribute to the complaint condition in the provided image.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot : manufacturing date: 12-apr-2021.Expiration date: 28-feb-2031.Production order traveler met all inspection acceptance criteria.Inspection sheet, in process / inspect dimensional / final, ns071295 rev f met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection, ns067861 rev b met all inspection acceptance criteria.Packaging label log lppf rev e, lmd rev a was reviewed and determined to be conforming.Scn 19772 supplied by ees (albuquerque) 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 parts reviewed: part number: 04.037.912.3 - tfna lock drive lot number: 84p0979.Lot quantity: (b)(4).One part was scrapped for anodize voids (ay) at op.50, final inspection.Production order traveler met all inspection acceptance criteria other than the one piece noted.Inspection sheet ns062925 rev e met all inspection acceptance criteria, aside from the one part that was scrapped.Part number: 04.037.942.2 - lock prong, 130 degree, tfna static locking prong lot number: 82p4698 lot quantity: (b)(4) production order traveler met all inspection acceptance criteria.Part number: 04.037.912.4 - wave spring, shim ended for tfna nail assembly lot number: 77p1355.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection ns062851 rev b met all inspection acceptance criteria.Material certification and certificate of conformance and quality history card supplied by smalley dated 21-jan-2021 was reviewed and found to be conforming.Part number: 21127 ¿ timoagri16.00 lot number: 57p4742.Lot quantity: 2,115 lbs.Inspection instruction met all inspection acceptance criteria.Certified test report received from perryman company dated 01-apr-2020 was reviewed and found to be conforming.Lot summary report dated 26-may-2020 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history review- 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: 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - 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
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13011296
• Report Number: 2939274-2021-07094
• Device Sequence Number: 1894173
• Product Code: HSB
• UDI-Device Identifier: 10886982096685
• UDI-Public: (01)10886982096685
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 04.037.160S
• Device Catalogue Number: 04.037.160S
• Device Lot Number: 98P6362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: NAIL DISTAL LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 68 KG