MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14.5MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE; NAIL, FIXATION, BONE

Model Number	03.010.438S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	10/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id also reported as (b)(6).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.(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 during a suprapatellar nailing on (b)(6) 2020, part of the protection sleeve was either reamed or cut.The surgeon needed to open the patient further to retrieve the piece.It was also reported that the screw missed the nail through the aiming arm.Procedure was completed successfully with a delay of thirty (30) minutes.Patient status was very good.This report is for a 14.5mm outer protection sleeve for suprapatellar.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.The 14.5mm outer protection sleeve for suprapatellar-sterile (p/n: 03.010.438s, lot #:42p3057) was returned and received at us cq.Upon visual inspection, it was observed that the device was broken and the broken fragments were returned.No other issues were identified with the returned device.Confirmed for the 14.5mm outer protection sleeve for suprapatellar-sterile (p/n: 03.010.438s, lot #:42p3057) there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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:03.010.438s, synthes lot number: 42p3057, supplier lot number: n/a, release to warehouse date: 05feb2020, expiration date: 30jun2022, supplier: (b)(4).No ncrs were generated during production.Device history batch = null.Device history review = review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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: 14.5MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10803423
• Report Number: 2939274-2020-04995
• Device Sequence Number: 3694338
• Product Code: JDS
• UDI-Device Identifier: 10886982068798
• UDI-Public: (01)10886982068798
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K111667
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 03.010.438S
• Device Catalogue Number: 03.010.438S
• Device Lot Number: 42P3057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Initial Date Received by Manufacturer: 10/11/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/03/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AIMING ARM FOR SUPRAPATELLAR; CANN CONNECTING SCREW; INSERTION HANDLE FOR SUPRAPATELLAR; UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA; AIMING ARM FOR SUPRAPATELLAR; CANN CONNECTING SCREW; INSERTION HANDLE FOR SUPRAPATELLAR; UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Weight: 100