MAUDE Adverse Event Report: SYNTHES GMBH CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

Catalog Number	314.05
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
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.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.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.
Event or Problem Description
It was reported that plates were implanted in the patient, the locking screws did not lock in 1-2 holes of the pl and medial plates so those plate holes were not filled.The surgeon initially used a va guide but later used a non locking drill guide.Unsure if it¿s because he used a metaphyseal screw first to suck the plate down, and then changed for a val.We¿ve had issues with this plate not locking, surgeon did not want patient to be charged.While inserting cortical screws and a 7.3 cannulated for the olecranon osteotomy he also complained of the screwdriver heads being stripped or warped.There were no patient outcomes reported.This report is for one (1) cannulated 4.0mm hexagonal screwdriver this is report 4 of 7 for complaint (b)(4).

• Brand Name: CANNULATED 4.0MM HEXAGONAL SCREWDRIVER
• Common Device Name: SCREWDRIVER
• 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: 18897658
• Report Number: 8030965-2024-03608
• Device Sequence Number: 15072020
• Product Code: HXX
• UDI-Device Identifier: 10886982188410
• UDI-Public: (01)10886982188410
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: 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: 314.05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.7/3.5 VA MEDL DSTL HUM PL 4H/LT/108-LG; 2.7/3.5 VA PSTLT DHP-LAT SUPT 4H/L/88-MD; SMALL HEXAGONAL SCRDRIVER HOLDING SLV; SMALL HEXAGONAL SCRDRIVER HOLDING SLV; UNK - SCREWS: METAPHYSEAL; UNK - SCREWS: METAPHYSEAL
• Patient Sex: Unknown