MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.045S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is synthes sales representative.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 (b)(6) 2020, the trochanteric fixation nail advanced (tfna) nail helical blade would not insert into the 430 degree hole.The guide wire was hitting the nail before insertion into the helical blade.The surgeon used another nail to complete the procedure.The issue was during surgery and there was an unknown surgical delay.It is unknown if procedure was successfully completed.Concomitant devices reported: unknown insertion instruments: trauma (part#: unknown, lot#: unknown, quantity 1).This report is for one (1) 10mm/130 deg ti cann tfna 235mm/left - sterile.This is report 1 of 3 for (b)(4).
Event or Problem Description
There was a surgical delay of three (3) to five (5) minutes.The procedure was successfully completed.The patient outcome is unknown.
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: manufacturing location: monument, manufacturing date: 27-may-2020, expiration date: 30-apr-2030, part number: 04.037.045s, 10mm/130 deg ti cann tfna 235mm/left ¿ sterile, lot number: 56p1235 (sterile), lot quantity: 6.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 was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 17923 supplied by ethicon (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 part(s) reviewed: component parts were not reviewed.The reported complaint condition of ¿helical blade will not go to the hole 430 degree¿ does not indicate breakage of the nail or any of its components.Therefore, a dhr review of the components 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.Visual inspection: 10mm/130 deg ti cann tfna 235mm/left ¿ sterile (part.No: 04.037.045s, lot.No: 56p1235, qty: 1) was returned and received at us customer quality (cq).Upon visual inspection at cq, no damage was observed with the device.Functional test: functional test cannot be performed at cq as the device was received by itself without any mating device.Can the complaint be replicated? unable to perform.Dimensional inspection: (gauge pins: gp29/ gp32).Dimensional inspection of the returned device was performed at cq.The diameter of the hole that helical blade passes through is within specification as per the drawing.Document/specification review: the following drawings were reviewed during the investigation: -ti cannulated trochanteric fixation nail-advanced, 130 degree -10mm dia cannulated trochanteric femoral nail-advanced 170mm & 200mm no design issues or discrepancies were noted during the investigation.Complaint confirmed? no.Investigation conclusion: the complaint could not be confirmed for 10mm/130 deg ti cann tfna 235mm/left ¿ sterile (part.No: 04.037.045s, lot.No: 56p1235).A definitive root cause for the reported problem could not be determined.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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.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: 10MM/130 DEG TI CANN TFNA 235MM/LEFT - 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: 10600529
• Report Number: 2939274-2020-04376
• Device Sequence Number: 19596754
• Product Code: HSB
• UDI-Device Identifier: 10886982096012
• UDI-Public: (01)10886982096012
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/03/2020

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: 04.037.045S
• Device Catalogue Number: 04.037.045S
• Device Lot Number: 56P1235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 10/23/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - GUIDES/SLEEVES/AIMING; UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - GUIDES/SLEEVES/AIMING; UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE