MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE, HUMERUS T2 HUMERUS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0143
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
As reported: this event occurred in the or as the surgeon was drilling through the proximal targeter connected to the humeral nail before inserting the proximal interlocks.The surgeon noticed the drill did not progress as it should have and found that the drill was missing the proximal interlocking screw holes in the nail.To correct this, the surgeon had to hold the proximal targeter upward slightly to help guide the drill bit in the correct trajectory.The surgeon was able to correctly drill through and add the proximal interlocks for the nail with some manual adjustments to the targeter.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is fully functional and is conforming to specifications.The device inspection revealed the following: the received target device shows normal signs of usage, overall.No visible damage or any deficiency was observed.A pre-surgical functional test was performed by assembling the returned target device with a sample nail, drill and a sleeve.Upon assembling it was found that the drill could pass through every hole on the nail without making any contact.Thus, the reported issue could not be reproduced and could not be confirmed.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.The returned device was conforming to specifications and was fully functional.Potentially reduced accuracy in guidance is usually found during functional check (required per labelling).In case of any deviation it is realized prior to use.Pre-operative testing is required in the labelling; maintaining measures during and after re-processing is also highlighted in the labelling.Although a real root cause could not be determined the alleged event was classified having been caused by a suboptimal intra-operative procedure and was regarded being user related.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: this event occurred in the or as the surgeon was drilling through the proximal targeter connected to the humeral nail before inserting the proximal interlocks.The surgeon noticed the drill did not progress as it should have and found that the drill was missing the proximal interlocking screw holes in the nail.To correct this, the surgeon had to hold the proximal targeter upward slightly to help guide the drill bit in the correct trajectory.The surgeon was able to correctly drill through and add the proximal interlocks for the nail with some manual adjustments to the targeter.

• Brand Name: TARGET DEVICE, HUMERUS T2 HUMERUS
• 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: 11794405
• Report Number: 0009610622-2021-00509
• Device Sequence Number: 4017181
• Product Code: LXH
• UDI-Device Identifier: 04546540196071
• UDI-Public: 04546540196071
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 1806-0143
• Device Catalogue Number: 18060143
• Device Lot Number: KME905205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 04/18/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1