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	06/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "consultant put 2 screws in the proximal holes through the targeter, both screws missed the nail.Before using the targeter the surgeon used a mallet on the targeter (even though advised against), we removed both screws and tightened the nail holding bolt on the targeter.Both screws then went through the nail and the targeter worked perfectly." the procedure was delayed by 20 min.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note the corrections to d9/h3 as the device was not returned for evaluation.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device disposition unknown.
Event or Problem Description
As reported: "consultant put 2 screws in the proximal holes through the targeter, both screws missed the nail.Before using the targeter the surgeon used a mallet on the targeter (even though advised against), we removed both screws and tightened the nail holding bolt on the targeter.Both screws then went through the nail and the targeter worked perfectly." the procedure was delayed by 20 min.
Additional Manufacturer Narrative
Please note the corrections to d9/h3 as the device was returned for evaluation.Please also note the corrections to h6 method, h6 results and h6 conclusion codes.The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the received target device shows traces of a long and intense use identified by the general appearance of the surfaces and by the appearance of the white printings, which turned from white to fawn (an indication for high sterilization cycles).The device also has little scratches over its surface.However, a 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 confirmed.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.Based on investigation, most likely the root cause was attributed to a user related issue.The failure was caused due to application error.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "consultant put 2 screws in the proximal holes through the targeter, both screws missed the nail.Before using the targeter the surgeon used a mallet on the targeter (even though advised against), we removed both screws and tightened the nail holding bolt on the targeter.Both screws then went through the nail and the targeter worked perfectly." the procedure was delayed by 20 min.

• 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15070826
• Report Number: 0009610622-2022-00333
• Device Sequence Number: 12141462
• Product Code: LXH
• UDI-Device Identifier: 04546540196071
• UDI-Public: 04546540196071
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/10/2023

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: KME901730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 08/09/2022; 12/13/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 09/02/2022; 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown