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

Model Number	1806-2035
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
It was reported that during a proximal humeral nail procedure on the patient's left side, the targeter would not release the soft tissue sleeve.The incisions were extended and three people were needed to back the construct out enough to remove the targeter.Surgery was completed successfully with a delay of approximately 30 minutes.
Additional Manufacturer Narrative
The alleged event was not confirmed.Review of dhr, labelling, capa database and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product.The reported event could not be confirmed.The alleged non-release of the tissue protection sleeve could not be reproduced.The function of the returned instruments was given in all aspects.Summarizing found facts the cause of the event was originated in inappropriate handling.In case other essential information becomes available were reserve the right to re-reopen the case for investigation and to assess a new root cause.
Event or Problem Description
It was reported that during a proximal humeral nail procedure on the patient's left side, the targeter would not release the soft tissue sleeve.The incisions were extended and three people were needed to back the construct out enough to remove the targeter.Surgery was completed successfully with a delay of approximately 30 minutes.

• Brand Name: TARGETING ARM T2 PROX. HUM.
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12962069
• Report Number: 0009610622-2021-00810
• Device Sequence Number: 5410198
• Product Code: LXH
• UDI-Device Identifier: 04546540379658
• UDI-Public: 04546540379658
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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
• Report Date (Section B): 02/16/2022

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: 1806-2035
• Device Catalogue Number: 18062035
• Device Lot Number: KHI012700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2020
• 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 Age: 54 YR
• Patient Sex: Male