MAUDE Adverse Event Report: STRYKER GMBH DISTAL TARGETING ARM FEMUR ANTEGRADE IMN INSTRUMENTS; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23533106
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device retained by the hospital.
Event or Problem Description
As reported: "during surgery of t2alpha-gt right, the sleeve did not reach the bone when using the distal device.Cause unknown.Maybe due to patient's anatomy.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.Lot# kme915035 was manufactured in three different batches.Since the serial # of the affected device was not communicated, it is not possible to know to which batch it corresponds.Therefore, the exact manufacturing date could not be determined.Nonetheless, the production documents of all three batches were reviewed.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "during surgery of t2alpha-gt right, the sleeve did not reach the bone when using the distal device.Cause unknown.Maybe due to patient's anatomy.".

• Brand Name: DISTAL TARGETING ARM FEMUR ANTEGRADE IMN INSTRUMENTS
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 18473483
• Report Number: 0009610622-2024-00016
• Device Sequence Number: 6794265
• Product Code: HSB
• UDI-Device Identifier: 07613327357066
• UDI-Public: 07613327357066
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• 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): 03/04/2024

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 Catalogue Number: 23533106
• Device Lot Number: KME915035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 60 YR
• Patient Sex: Male