MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BOTTOM LOADING CAP GUIDE; SURGICAL, MISC, ORTHO, INSTRUMENT

Catalog Number	03.616.051
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.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 conclusion could be drawn at the time of filing this report.Investigation summary could not been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.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
Device report from synthes reports an event in canada as follows: it was reported that dr.Weber was performing a matrix mis case, levels were l4-l5 and he wanted to remove the cap, unfortunately, the nurse gave the cap guides in order to proceed with the cap removals and the surgeon therefore broke the both short cap guides.The issue was the end tip of the cap guides (where one of the arms was significantly damaged/ bent and barely holding).The items are not available for return due to the current covid 19 situation.Concomitant device reported: unknown cap (part# unknown, lot# unknown, quantity 1).This complaint involves 2 devices.This report is for 1 bottom loading cap guide.This report is 2 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.
Event or Problem Description
Additional event information: the surgeon wanted to remove the rod to replace it with a longer one and the rod was already implanted.
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.
Event or Problem Description
Device report from synthes reports an event in canada as follows: it was reported that on (b)(6) 2020 during a matrix mis case, levels were l4-l5, the surgeon wanted to remove the cap.The cap needed to be removed, due to the fact that the rod was too short.Unfortunately, the nurse gave the cap guides in order, to proceed with the cap removals, which caused both short cap guides to break.The issue was at the end tip of the cap guides, where one of the arms was significantly damaged/bent and barely holding.Another set was used to complete the surgery.There was no surgical delay.No fragments were generated.The surgery was completed successfully.There was no reported consequence to the patient.Concomitant devices reported: bottom loading cap guide (part 03.616.051, lot unknown, quantity 1), cap (part number unknown, lot unknown, quantity 1), rods (part number unknown, lot unknown, quantity 1).This report involves one (1) bottom loading cap guide.This is report 2 of 3 for (b)(4).

• Brand Name: BOTTOM LOADING CAP GUIDE
• Common Device Name: SURGICAL, MISC, ORTHO, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10022247
• Report Number: 2939274-2020-02232
• Device Sequence Number: 11466423
• Product Code: LXH
• UDI-Device Identifier: 07611819417472
• UDI-Public: (01)07611819417472
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2020

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 Catalogue Number: 03.616.051
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 05/07/2020; 05/13/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 05/11/2020; 05/26/2020
• 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: CAP GUIDE ONE-STEP; CAP GUIDE ONE-STEP; UNK - RODS; UNKNOWN CAP; UNKNOWN CAP