MAUDE Adverse Event Report: SYNTHES GMBH CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8; SCREWDRIVER

Catalog Number	03.226.004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.Part: 03.226.004; lot: l182329.Manufacturing site: (b)(6).Supplier: (b)(6).Release to warehouse date: (b)(6) 2017.Expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Investigation summary: the complaint device (scrdriver shaft cann t8 w/colour-marking) was not received for investigation.A photo investigation was performed based on the received image.The image was reviewed, and the complaint condition is confirmed.The tip of the screwdriver appears to be broken, fragments are visible in the evidence provided.A definite assignable root cause could not be determined based on the provided information.As the device was not returned, and as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 the (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2022, a screwdriver belonging to the hcs 2.4mm set broke.All small fragments from the screwdriver were retrieved from the surgical site.The surgeon used a non-cannulated screwdriver to finish the procedure.Procedure was completed successfully with approximately twenty minutes delay.There was no patient consequence.This report is for a cannulated stardrive scrwdrvr shaft for 3.0mm hcs t8.This is report 1 of 1 for (b)(4).

• Brand Name: CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8
• Common Device Name: SCREWDRIVER
• 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: 13636562
• Report Number: 8030965-2022-01233
• Device Sequence Number: 20093645
• Product Code: HXX
• UDI-Device Identifier: 07611819194304
• UDI-Public: (01)07611819194304
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,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: 03.226.004
• Device Lot Number: L182329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2017
• 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