MAUDE Adverse Event Report: STRYKER GMBH STRAIGHT REDUCTION CLAMP, BROAD VARIAX2

Catalog Number	705297
Medical Device Problem Codes	Material Fragmentation (1261); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The forceps was damaged at the tip, resulting in a fragment.The fragment was removed from the patient body.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned and matches the alleged failure.The device inspection revealed the following: tip of the reduction clamp found completely broken and the remaining broken fragment was not returned.Intense usage marks clearly visible all over on the surface of the device which indicates that the device is pretty much old and is in use since long which is further confirmed by the faded markings on the device.There are some damage marks proximal to the broken portion on the teeth of the clamp which indicates that excess force being applied on the device during clamping.Due to application of excess force, a brittle failure occurred in device which is further confirmed by the formation of shear lip and smooth breakage surface in microscopic view.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with the values in the material specification.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 investigation, the root cause was attributed to be a user related issue as the breakage was caused due to the application of excess stress leading to brittle failure.However, an nc had been previously initiated to investigate the recurring situation.If more information is provided, the case will be reassessed.
Event or Problem Description
The forceps was damaged at the tip, resulting in a fragment.The fragment was removed from the patient body.

• Brand Name: STRAIGHT REDUCTION CLAMP, BROAD VARIAX2
• 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: 19929380
• Report Number: 0008031020-2024-00302
• Device Sequence Number: 19522976
• Product Code: HXD
• UDI-Device Identifier: 07613327125252
• UDI-Public: 07613327125252
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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: 705297
• Device Lot Number: L28858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2018
• 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: Unknown