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	08/02/2023
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.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : device disposition unknown.
Event or Problem Description
As reported: "during t2alpha gt surgery, the sleeve inserted to the distal device did not contact with the bone.As a result, the depth gauge measurement was ambiguous, and the screwdriver was not long enough to insert the screw.".

• 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: 17637565
• Report Number: 0009610622-2023-00297
• Device Sequence Number: 20456053
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2023

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 Catalogue Number: 23533106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 08/28/2023
• 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 Sex: Unknown