MAUDE Adverse Event Report: SYNTHES GMBH 2.5MM PERCUTANEOUS WIRE GUIDE F/5.0MM LCKNG SCREWS; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	324.215
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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 synthes reports an event in (b)(6) as follows: it was reported that during an unknown procedure on (b)(6) 2020, the hexagonal pin wrench did not fit and engaged to the percutaneous guides for both the drill and the guidewire.Once these percutaneous guides are screwed into the plate one need the pin wrench to disengage the percutaneous guides off the plate and the current hexagonal pin wrench in the set, does not fit in the hole to do this.There was a longer operative time due to not having correct instrument for the use of the set.Procedure was successfully completed.No further information available.Concomitant devices reported: 4.0mm hex key (part # 03.120.029, lot # unknown, quantity 1), 4.3mm percutaneous threaded drill guide (part # 324.203, lot # unknown, quantity 1).This report is for one (1) 2.5mm percutaneous wire guide f/5.0mm lckng screws.This is report 2 of 3 for complaint (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.H10 additional narrative: 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
The hexagonal pin wrench was reported to not fit the instruments that it was supposed to.The pin wrench is altered so that it can be used.

• Brand Name: 2.5MM PERCUTANEOUS WIRE GUIDE F/5.0MM LCKNG SCREWS
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10938382
• Report Number: 8030965-2020-09355
• Device Sequence Number: 558381
• Product Code: FZX
• UDI-Device Identifier: 07611819915367
• UDI-Public: (01)07611819915367
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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: 324.215
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/27/2021
• 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: DRILL GUIDE Ø4.3 PERCUT; HEX-PIN WRENCH ÿ4 W/BALL TIP; DRILL GUIDE Ø4.3 PERCUT; HEX-PIN WRENCH ÿ4 W/BALL TIP