MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 120°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3120-1180S
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
Customer reported the following issue regarding a gamma nail ref.3120-1180s, lot k05cc65 and the ancillary material necessary for its installation (nail, target device, bolt): "during an operation on (b)(6) 2021, the material was fitted without any problems until the nail had to be removed from the target device to complete the operation: it was impossible to unscrew.The consequences were a doubling of the operation time due to the need to remove everything to start the whole operation again, and the need to use another ancillary and another nail less adapted to the patient".
Additional Manufacturer Narrative
Correct: please refer to d9/h3 device not returned.The reported event could not be confirmed, since the device was not returned for evaluation and no additional information was provided for evaluation.A device inspection was not possible since the affected device was not returned and no other evidence was provided for investigation.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.A review of the labeling did not indicate any abnormalities.More information as well as the affected device must be available in order to determine the exact root cause of the issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text: device disposition is unknown.
Event or Problem Description
Customer reported the following issue regarding a gamma nail ref.(b)(4), lot k05cc65 and the ancillary material necessary for its installation (nail, target device, bolt): "during an operation on (b)(6) 2021, the material was fitted without any problems until the nail had to be removed from the target device to complete the operation: it was impossible to unscrew.The consequences were a doubling of the operation time due to the need to remove everything to start the whole operation again, and the need to use another ancillary and another nail less adapted to the patient".

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 120°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 12849558
• Report Number: 0009610622-2021-00795
• Device Sequence Number: 11930104
• Product Code: HSB
• UDI-Device Identifier: 04546540375025
• UDI-Public: 04546540375025
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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: 3120-1180S
• Device Catalogue Number: 31201180S
• Device Lot Number: K05CC65
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown