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

Model Number 705297

Device Problems Break (1069); Fracture (1260)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2021

Event Type  malfunction  

Event Description

As reported: "the tip of the product was damaged due to a strong pull when it was used during restoration." update 12/28/2021: the tip of instrument is broken.Other instruments were used to complete the procedure.

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "the tip of the product was damaged due to a strong pull when it was used during restoration." **update (b)(6) 2021: the tip of instrument is broken.Other instruments were used to complete the procedure.

Manufacturer Narrative

Please note correction to section h6 (clinical signs and health impact codes).The reported event could be confirmed, since the device was returned for evaluation, and matches the alleged failure.The device inspection revealed the following: the received clamp overall showed normal signs of usage with one of its legs broken.The fracture pattern on the surface of the broken leg indicates a typical brittle fracture under immense bending load.No other deformation was observed around the breakage point, indicating an instantaneous breakage under a high load.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design-related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause of the failure is user related.The breakage of one of the legs of the clamp occurred due to intra-op excessive bending load application on the leg, more than it could sustain.Ultimately leading to an instantaneous brittle fracture.If any additional information is provided, the investigation will be reassessed.

• Brand Name: STRAIGHT REDUCTION CLAMP, BROAD VARIAX2
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13157823
• MDR Text Key: 284898676
• Report Number: 0008031020-2022-00001
• Device Sequence Number: 1
• Product Code: HXD
• UDI-Device Identifier: 07613327125252
• UDI-Public: 07613327125252
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 705297
• Device Catalogue Number: 705297
• Device Lot Number: L28818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2018
• 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