MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MULTI HOLE WIRE GUIDE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.037.000
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Product was not returned.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
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 the helical aim arm lock device with the silver push attachment was catching on the bone and would not release.Also, the t handle ball driver could not be turned when up against the patient, the driving cap broke off, the multi hole wire guide was difficult to remove during surgery and the helical/screw extractor is difficult to change the length of the guide wire once the blade is in place.There was a twenty (20) minute surgical delay.This report is for one (1) multi hole wire guide.This is report 3 of 5 for (b)(4).

• Brand Name: MULTI HOLE WIRE GUIDE
• 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: 12745029
• Report Number: 2939274-2021-06459
• Device Sequence Number: 11940608
• Product Code: FZX
• UDI-Device Identifier: 07611819642270
• UDI-Public: 07611819642270
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2021

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 03.037.000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 11/03/2021
• 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: DRIVING CAP F/INSERTION HANDLE; EXTRACT-INSTR F/TFNA HELIC BLADE+SCR; LOCK-INSERT F/AIMING ARM; SCRDRIVER-HEX Ø8 W/T-HANDLE W/SPHERIC-HE
• Outcome Attributed to Adverse Event: Required Intervention