MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.8MM INTERLOCKING BOLT FOR PERCUTANEOUS INSERTION HANDLE; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.124.006
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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) 2020, the patient underwent an open reduction internal fixation (orif) right lateral tibia plateau fracture.During the procedure, the cannulated interlocking bolt would not thread into the percutaneous aiming arm hole of a lateral proximal tibia plate.The procedure was successfully completed with a five (5) minute surgical delay.The patient outcome was good.Concomitant device reported: unknown nut (part#: unknown, lot#: unknown, quantity: 1); unknown insertion handle (part#: unknown, lot#: unknown, quantity: 1).This report is for one (1) 2.8mm interlocking bolt for percutaneous insertion handle.This is report 2 of 3 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.H10 additional narrative: h3, h6: investigation summary: investigation flow: device interaction/functional.Visual inspection: the 2.8mm interlocking bolt for percutaneous insertion handle (part # 03.124.006, lot # 7907487) was received at us cq.Upon visual inspection, it was observed that the distal threaded tip of the device was stripped.The very distal portion of the tips were rounded, almost worn to the core.Due to the worn condition of the tip, device functionality was compromised.The noted issues were consistent as end of life indicators for the device.The stripped condition confirms the reported device assembly issue.Conclusion: the complaint was confirmed for the received device.After a visual inspection per guidance provided in windchill document # (b)(4), it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part number: 03.124.006; lot number: 7907487; manufacturing site: hägendorf; release to warehouse date: june 21, 2012.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.
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 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: 2.8MM INTERLOCKING BOLT FOR PERCUTANEOUS INSERTION HANDLE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10772370
• Report Number: 2939274-2020-04932
• Device Sequence Number: 4086440
• Product Code: FZX
• UDI-Device Identifier: 10886982075000
• UDI-Public: (01)10886982075000
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2020

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: 03.124.006
• Device Catalogue Number: 03.124.006
• Device Lot Number: 7907487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 11/06/2020; 11/04/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 11/27/2020; 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - NUTS; UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - NUTS
• Patient Age: 48 YR