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

Catalog Number 705461

Device Problems Break (1069); Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2023

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that the instrument broke during ordinary use.

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 Description

It was reported that the instrument broke during ordinary use.

• Brand Name: JUNGBLUTH CLAMP FOR 3.5MM SCREWS, WIDE PRO
• Type of Device: 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
• MDR Text Key: 316351428
• Report Number: 0008031020-2023-00209
• Device Sequence Number: 1
• Product Code: HXD
• UDI-Device Identifier: 07613327131871
• UDI-Public: 07613327131871
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 100 KG