MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TRIAL IMPLANT MEDIUM-5MM; TEMPLATE

Model Number	03.820.025
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 at the time of filing this report.A review of the device history records has been requested.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) 2019, during the prodisc c arthroplasty procedure, the prodisc-c trial implant became stuck in the trial inserter.Once removed it would no longer attach to the inserter.The procedure was successfully completed by using the trial without the trial inserter.There was a 15-minute surgical delay.Patient outcome has no issues.Concomitant device reported: trial implant medium-5mm (part #: 03.820.025, lot #: a7qa48, quantity: 1).This complaint involves two (2) devices.This report is 1 of 2 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.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.Product was not returned.Based on the information available, it has been determined that no corrective and 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.A review of the device history records was performed for the finished device lot number, and no non-conformance were identified.

• Brand Name: TRIAL IMPLANT MEDIUM-5MM
• Common Device Name: TEMPLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8567076
• Report Number: 2939274-2019-57746
• Device Sequence Number: 2257257
• Product Code: HWT
• UDI-Device Identifier: 10705034731186
• UDI-Public: (01)10705034731186
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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: 03.820.025
• Device Catalogue Number: 03.820.025
• Device Lot Number: T947863
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 05/30/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRIAL IMPLANT MEDIUM-5MM