MAUDE Adverse Event Report: SYNTHES GMBH STARDRIVE SCREWDRIVER T8

Catalog Number	03.110.007
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During routine medical device reprocessing, medical device reprocessing staff noticed that the shaft of the complained item became loose at the connection point to the rest of the instrument.Also, staff identified that star-drive tip of the item became deformed and would no longer function to fit into a t8 screw head recess.A third discovery was made by staff that the tip of item had become stripped and would no longer properly engage the screw head recess of a star-drive screw.These 3 instruments were deemed to be no longer functional and were subsequently discarded.No additional information is available.This report is for one (1) stardrive screwdriver t8.This is report 1 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.D9: complainant part is not expected to be returned for manufacturer review/investigation.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.

• Brand Name: STARDRIVE SCREWDRIVER T8
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• 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: 20246617
• Report Number: 8030965-2024-11409
• Device Sequence Number: 12590720
• Product Code: HXX
• UDI-Device Identifier: 07611819352230
• UDI-Public: (01)07611819352230
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

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: 03.110.007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T; SCRDRIVER 2.4 STARDRIVE T8 SELF-HOLDING; SD/HD SCRDRIVER T25 3.5 HEX/SELF-RETAIN
• Patient Sex: Unknown