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

Catalog Number 23533106

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 322113873
• Report Number: 0009610622-2023-00297
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327357066
• UDI-Public: 07613327357066
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 23533106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1