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

Model Number 705297

Device Problems Break (1069); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the available information the device will not be returned; therefore, an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device was discarded.

Event Description

As reported: "tip of a point to point reduction forcep snapped off during reduction of a bone in a procedure.Tip was recovered and the instrument was passed off.A different reduction forcep was used.".

Event Description

As reported: "tip of a point to point reduction forcep snapped off during reduction of a bone in a procedure.Tip was recovered and the instrument was passed off.A different reduction forcep was used.".

Manufacturer Narrative

The reported event could be confirmed from the provided images of the product.From the picture straight reduction clamp, we can see the tip is broken further product is required to do complete analysis of failure pattern.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16457337
• MDR Text Key: 310410031
• Report Number: 0008031020-2023-00096
• Device Sequence Number: 1
• Product Code: HXD
• UDI-Device Identifier: 07613327125252
• UDI-Public: 07613327125252
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• 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: L28798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2018
• 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
• Patient Age: 58 YR
• Patient Sex: Male