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	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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) 2021, during hip surgery, the bolt for femoral neck system (fns) failed.It was mentioned that the implant was still in the early stages of its life.The pre-op fixation wasn¿t valgus impacted and already high degree of stress across sub cap border.It is unknown if there was surgical delay.Procedure outcome and patient status are unknown.Concomitant device reported: unknown locking screw (part#: unknown, lot#: unknown, quantity: 1).Unknown antirotation screw fns (part#: unknown, lot#: unknown, quantity: 1).Unknown plate fns (part#: unknown, lot#: unknown, quantity: 1).This complaint involves one (1) device.This report involves one (1)bolt for femoral neck system 85mm length-sterile.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6: customer quality investigation: the implant(s) was not returned, and the investigation will be completed based on the supplied image(s).The image(s) was reviewed, and the complaint condition(s) of migration was confirmed as the image(s) shows the bolt migrating from the bone.As the implants) was not returned and an as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image.There is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 11231267
• Report Number: 2939274-2021-00492
• Device Sequence Number: 3360521
• Product Code: KTT
• UDI-Device Identifier: 10886982274731
• UDI-Public: (01)10886982274731
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.168.285S
• Device Catalogue Number: 04.168.285S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 02/04/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; UNK - PLATES: FNS; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention