MAUDE Adverse Event Report: STRYKER GMBH TARGET DEVICE GAMMA3® 300X160MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 13200100

Device Problems Positioning Failure (1158); Failure to Align (2522)

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

Event Date 07/10/2023

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "guide hole does not meet hole position in nail".

Manufacturer Narrative

The reported event could not be confirmed.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.The identification of the device could be confirmed based on the catalog # and lot # marked.The received target device gamma 3 shows traces of a frequent and intense use, with multiple usage marks observed all over the device.The printings on the target device were turned from white to fawn and are partly worn; an indication for a high level of sterilization cycles during 15 years of use.The target device returned is an of old design version.A simulation of a surgical function test was performed on the returned device.The drills passed the nail's holes with no contact.The alleged mis-targeting could not be reproduced.Therefore, the function of the target device was still given.Based on investigation, the root cause was attributed to a user related issue.A deficiency of the returned device was not verified.

Event Description

As reported: "guide hole does not meet hole position in nail".

• Brand Name: TARGET DEVICE GAMMA3® 300X160MM
• 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: 17462041
• MDR Text Key: 320683752
• Report Number: 0009610622-2023-00270
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: 04546540716774
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13200100
• Device Lot Number: KME902056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2008
• 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