MAUDE Adverse Event Report: SYNTHES GMBH 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	323.034
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that on november 20, 2023, the patient underwent an unknown surgery with the distal ulna plate and the drill guide.The surgeon commented that it was very difficult to install the drill sleeve to the proximal 4 holes of the plate shaft.The surgery was completed successfully within 30 minutes delay.The patient was reported as stable.This report involves one (1) 1.5mm threaded drill guide with depth gauge.This is report 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E1 initial reporter facility name: (b)(6).E3: reporter is a j&j employee.H3, h4, h6: 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.

• Brand Name: 1.5MM THREADED DRILL GUIDE WITH DEPTH GAUGE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18317391
• Report Number: 8030965-2023-15623
• Device Sequence Number: 12331872
• Product Code: FZX
• UDI-Device Identifier: 07611819156586
• UDI-Public: 07611819156586
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 323.034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LCP DIST-ULNAPL2 W/HOOKS 7HO L46 TI
• Patient Sex: Unknown