MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC IMPLANT INSERTER; MISC ORTHO SURGICAL INSTR

Model Number	03.820.129
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Part: 03.820.129, lot: t921187; manufacturing site: (b)(4).Release to warehouse date: march 27, 2008.A review of the device history records was performed for the finished device lot number no relevant nonconformance's were found.He instrument(s) was not returned and investigation instead will be done based on the supplied image(s) from the attachments.The image(s) (1 total) was reviewed and the complaint condition could be confirmed as the image(s) shows the weld between the center guide and the stop has failed resulting in the proximal end being broken off from the rest of instrument.As the instrument(s) was not returned an as received, dimensional, material or drawing reviews are not applicable.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation, no unidentified product design/manufacturing issues or discrepancies were observed (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.
Event or Problem Description
It was reported on (b)(6) 2019, during the surgery there was an unknown issue observed with the prodisc-c (pdc) implant inserter.Procedure and patient outcome are unknown.Upon manufacturer receipt and investigation, it was determined that the device is broken.This report is for an implant inserter.

• Brand Name: IMPLANT INSERTER
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8755596
• Report Number: 2939274-2019-58984
• Device Sequence Number: 16625669
• Product Code: LXH
• UDI-Device Identifier: 10705034731681
• UDI-Public: (01)10705034731681
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2019

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: 03.820.129
• Device Catalogue Number: 03.820.129
• Device Lot Number: T921187
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1