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

Model Number	705297
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported the tip of the product broke during the operation.
Event or Problem Description
It was reported the tip of the product broke during the operation.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.Device inspection revealed the following: the received clamp overall showed normal signs of usage with one of its leg broken.The fracture pattern on the surface of the broken leg indicates typical brittle fracture under immense bending load.No other deformation was observed around the breakage point, indicating towards an instantaneous breakage under a high load.The average hardness of the reduction clamp was observed to be 46.4 hrc as required against a range of 44.0 hrc ¿ 48.0 hrc.The returned screwdriver bit was found to be within specifications.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 material, 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.The brochure instructions for cleaning, sterilization, inspection and maintenance guide clearly mentions: ¿stryker trauma & extremities typically does not specify the maximum number of uses appropriate for re-usable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.[¿] careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.¿ if any further information is provided, the complaint report will be updated.

• Brand Name: STRAIGHT REDUCTION CLAMP, BROAD VARIAX2
• Common Device Name: CLAMP
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11794397
• Report Number: 0008031020-2021-00214
• Device Sequence Number: 1021322
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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 Model Number: 705297
• Device Catalogue Number: 705297
• Device Lot Number: L28858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 07/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1