MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE; APPLIANCE,FIXATION,NAIL

Model Number	04.168.285S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2019
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 product was received; 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 during a displaced femoral head fixing procedure on (b)(6) 2019, the 85mm fns bolt was removed shortly after it was implanted.The surgeon felt that the reported bolt was initially too short.The procedure was successfully completed with the use of 90mm fns bolt.It is unknown if there was a surgical delay.There was no patient consequence.Concomitant device reported: fns plate (part # 04.168.000s-us, lot # 3l31912, quantity 1), antirotation screw (part # 04.168.485s, lot # 3l12978, quantity 1), locking screw (part # 412.212s, lot # 2l56179, quantity 1).This is report 01 of 01 of (b)(4).Related product complaint: (b)(4).
Additional Manufacturer Narrative
Product complaint #: (b)(4).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: investigation summary product was not returned.Based on the information available, it has been determined that no corrective and 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.H3, h4, h6: a review of the device history record.Device history lot: part: 04.168.285s, lot: 3l12777, manufacturing site: grenchen, release to warehouse date: 29 jan 2019, expiry date: 31 dec 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9647962
• Report Number: 2939274-2020-00556
• Device Sequence Number: 401149
• Product Code: KTT
• UDI-Device Identifier: 10886982274731
• UDI-Public: (01)10886982274731
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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: 04.168.285S
• Device Catalogue Number: 04.168.285S
• Device Lot Number: 3L12777
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 02/26/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOCKSCR Ø5 SELF-TAP L36 TAN; PL 1-HO F/FEM NECK SYST TAN; UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION