MAUDE Adverse Event Report: STRYKER GMBH JUNGBLUTH CLAMP FOR 3.5MM SCREWS, WIDE PRO

Catalog Number	705461
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the instrument broke during ordinary use.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, and matches the alleged failure.Device inspection revealed the following: the received jungbluth clamp shows discoloration throughout the surface which is from usage and regular reprocessing cycles.We can see that the cap of the hinge pin is missing, and the hinge pin is broken inside the mating part which was not returned for the investigation.From the microscopic view of the broken area, we can see a clear brittle shiny surface which was due to the application of excessive torsional load.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on the investigation, the root cause was attributed to user-related as we can see clear sign of excessive torsional load.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the instrument broke during ordinary use.

• Brand Name: JUNGBLUTH CLAMP FOR 3.5MM SCREWS, WIDE PRO
• Common Device Name: CLAMP
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17010924
• Report Number: 0008031020-2023-00209
• Device Sequence Number: 7253242
• Product Code: HXD
• UDI-Device Identifier: 07613327131871
• UDI-Public: 07613327131871
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023
• 2 Devices were Involved in the Event: 1 2

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: 705461
• Device Lot Number: L14659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 100 KG