MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.315S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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) 2019 while using a trochanteric fixation nail (tfn) nail the surgeon missed the nail when drilling and it resulted in the screw missing the nail.The surgeon tried to redo it but decided to leave it outside the nail.It was unknown if there was a surgical delay.Procedure outcome and patient status are unknown.This report is for one (1) 10mm/130 deg ti cann troch fixation nail 170mm-sterile.This is report 7 of 7 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.Device history lot.Manufacturing location: monument.Manufacturing date: dec 08, 2017.Expiration date: nov 30, 2026.Part number: 456.315s, 10mm/130 deg ti cann troch fixation nail 170mm ¿ sterile.Lot number: h519992 (sterile).Lot quantity: 6.Work order traveler met all inspection acceptance criteria.Inspection sheet, in process/inspect dimensional/final, ns054634 rev j met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev k was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 14461 supplied by ethicon (abq) was reviewed and determined to be conforming.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿targeting device for distal screw missed the nail¿ does not indicate breakage of the nail or any of its components and, therefore, a review of the raw materials would not be pertinent to the reported complaint condition.Device history review.(b)(6) 2019: dhr reviewed.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: 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-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: 9336962
• Report Number: 2939274-2019-62274
• Device Sequence Number: 2243953
• Product Code: HSB
• UDI-Device Identifier: 10886982226907
• UDI-Public: (01)10886982226907
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• 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): 11/02/2019

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: 456.315S
• Device Catalogue Number: 456.315S
• Device Lot Number: H519992
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 12/13/2019
• Patient Sequence Number: 1
• Patient Weight: 54