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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: product was not returned.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 history lot: part: 04.168.285s, lot: 3l12777, manufacturing site: (b)(4), release to warehouse date: jan 29, 2019, expiry date: dec 31, 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.
Event or Problem Description
It was reported that on (b)(6) 2020, the patient underwent a revision surgery due to displacement of the femoral head from the neck.Initially the patient was implanted with the reported femoral neck system (fns) devices on (b)(6) 2019.During the revision procedure all the fns devices were successfully removed and the patient was then revised to hemi arthroplasty left hip.The 85mm bolt was removed during the initial surgery and replaced with the 90mm bolt as the surgeon felt that the 85mm bolt was initially too short.The 90mm bolt was the item removed during the revision surgery.The procedure as successfully completed without any surgical delay.Patient status was unknown.This report is for one (1) bolt for femoral neck system 85mm length-sterile.This is report 2 of 5 (b)(4).Related product 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.H11the initial complaint was reviewed and found to be a duplicate of another reported complaint pc-000644559 and the information for this event is captured on manufacture report number 2939274-2020-00556.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: 9641235
• Report Number: 2939274-2020-00444
• Device Sequence Number: 2139437
• 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
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• 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?: Yes
• Is this a Product Problem Report?: No
• 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: 01/20/2020
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention