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

Catalog Number	705297
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
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
As reported: "the instrument could not resist the force to reduce the bone and broke.".
Additional Manufacturer Narrative
Please note correction to d4 (lot/serial no.).The reported event could be confirmed since the device was returned and matches the alleged failure.The device inspection revealed the following: the received reduction clamp was visually checked, and one of the tip of reduction clamp found completely broken off.Also, severe rubbing marks of usage clearly visible in the proximal areas of tip.The breakage of the tip shows the characteristics of a brittle failure with smooth surface and without any plastic deformation suggesting that the portion being subjected to excess stress leading to sudden breakage of the component.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 sudden breakage.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the instrument could not resist the force to reduce the bone and broke.".

• 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: 18691823
• Report Number: 0008031020-2024-00088
• Device Sequence Number: 17910033
• Product Code: HXD
• UDI-Device Identifier: 07613327125252
• UDI-Public: 07613327125252
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male