MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM T2 ANKLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-3212
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: during surgery the posterior screw could not be inserted because the drill bit hit the nail through the sleeve on the target device.I also inserted the t2 ankle nail into the target device afterwards - no drill bit fits through the sleeve into the lateral static/dynamic hole.
Event or Problem Description
As reported: during surgery the posterior screw could not be inserted because the drill bit hit the nail through the sleeve on the target device.I also inserted the t2 ankle nail into the target device afterwards - no drill bit fits through the sleeve into the lateral static/dynamic hole.
Event or Problem Description
As reported: during surgery the posterior screw could not be inserted because the drill bit hit the nail through the sleeve on the target device.I also inserted the t2 ankle nail into the target device afterwards - no drill bit fits through the sleeve into the lateral static/dynamic hole.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and is fully functional.A review of the device history for the reported lot did not indicate any abnormalities.A review of the labelling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.A nc / capa was not in place for this product with this failure mode.No corrective actions are required at this time.The device returned passed the pre-operative function test as intended.Function was given in full.Potentially reduced accuracy in guidance is usually found during functional check (required per ifu).In case of any deviation it is realized prior to use.Although a root cause could not be determined the alleged event is most likely caused due to a suboptimal intra-operative procedure and has to be classified as user-customer-user error.In case further substantial information becomes available we reserve the right to re-open the investigation including re-assessment of root cause.

• Brand Name: TARGETING ARM T2 ANKLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10279835
• Report Number: 0009610622-2020-00323
• Device Sequence Number: 19093979
• Product Code: LXH
• UDI-Device Identifier: 04546540708496
• UDI-Public: 04546540708496
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2020

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: 1806-3212
• Device Catalogue Number: 18063212
• Device Lot Number: KME910553 - 247132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 09/17/2020; 11/10/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 10/12/2020; 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1