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

Model Number	4960-3-000
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem 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.".
Additional 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 or Problem 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
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11791033
• Report Number: 0008031020-2021-00212
• Device Sequence Number: 1021321
• Product Code: KTT
• UDI-Device Identifier: 04546540492791
• UDI-Public: 04546540492791
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 08/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention