MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BOLT FOR FEMORAL NECK SYSTEM 95MM LENGTH-STERILE; APPLIANCE,FIXATION,NAIL

Model Number	04.168.295S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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 history lot: part/lot combination are unknown at synthes gmbh, no dhr review possible.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 november 9, 2020, during an unknown procedure, when the surgeon had to remove the femoral neck plate due to pain, the locking screw was locked into the plate and it would not come out so the surgeon used an unknown metal cutting burr to cut into the plate.The surgeon was then able to back out the locking screw and was also able to remove the anti-rotation screw, the bolt and the plate.Fragments were generated and easily removed without additional intervention.The procedure was completed successfully with a surgical delay of five (5) minutes.There was no patient consequence reported.This report is for one (1) bolt for femoral neck system 95mm length-sterile.This is report 2 of 4 for (b)(4).

• Brand Name: BOLT FOR FEMORAL NECK SYSTEM 95MM 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: 10951130
• Report Number: 2939274-2020-05462
• Device Sequence Number: 3170575
• Product Code: KTT
• UDI-Device Identifier: 10886982274755
• UDI-Public: (01)10886982274755
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2020

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: 04.168.295S
• Device Catalogue Number: 04.168.295S
• Device Lot Number: 2L32120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 12/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention