MAUDE Adverse Event Report: STRYKER GMBH LENGTHENER ASSEMBLY HOFFMANN II MICRO; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 4960-3-000

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 04/12/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported: "the external fixator of the patient operated on (b)(6) was damaged on (b)(6).For replacement work by urgent arrangement on the day.".

Manufacturer Narrative

The reported event could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by the mishandling of the part and to its normal wear.The device and related documentation was examined, and the following points were found: it failed on two different laser welding seams.Both sites of failure were part of a 100% inspection, without any deviations found, all parts passed.Moreover, the part fully met the material specifications.Based on the points mentioned above, we assume that there was a handling error which led to the failure of the part.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.If any further information is provided, the complaint report will be updated.

Event Description

As reported: "the external fixator of the patient operated on january 28 was damaged on april 12.For replacement work by urgent arrangement on the day.".

• Brand Name: LENGTHENER ASSEMBLY HOFFMANN II MICRO
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11791033
• MDR Text Key: 251713544
• Report Number: 0008031020-2021-00212
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 04546540492791
• UDI-Public: 04546540492791
• Combination Product (y/n): N
• PMA/PMN Number: K052037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4960-3-000
• Device Catalogue Number: 49603000
• Device Lot Number: L38958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention