MAUDE Adverse Event Report: SYNTHES GMBH HANDLE FOR 90° SCREWDRIVER; SCREWDRIVERS

Catalog Number	03.505.004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device reported as broken and repairable.No further information is available.
Additional Manufacturer Narrative
This report is 1 of 1 on (b)(4).Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.Device history: part # 03.505.004.Lot # 8071367.Manufacturing site: (b)(4).Release to warehouse date: 27 sep 2007.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: HANDLE FOR 90° SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13906052
• Report Number: 8030965-2022-01959
• Device Sequence Number: 17162455
• Product Code: HXX
• UDI-Device Identifier: 07611819187481
• UDI-Public: 07611819187481
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082649
• 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: 03.505.004
• Device Lot Number: 8071367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2007
• 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
• Patient Sex: Unknown