MAUDE Adverse Event Report: STRYKER GMBH G4 TARGETING SLEEVE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	14200110
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the sleeve for gamma4 was not working correctly.It wouldn't lock in.(b)(6) 2024-update: intra-op-sleeve was not locking to targeting guide.Triple sleeve typically lines into the drill hole for the nail, but because the guide was not engage, it was going posterior to the nail, and the nail was missed.Had to take off the guides and do perfect circles.And complete the surgery free hand.Longer or time 20-25 mins.Metal circular piece needed to be malleted down to function as expected.
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 is unknown.
Additional Manufacturer Narrative
Please note corrections to sections b1, b2 and h1.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.Referring to previous investigations the event cannot be excluded.A review of the device history for the reported lot did not indicate any abnormalities.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.In the case presented, the sleeve for gamma4 was not working correctly, it wouldn't lock in.The sales rep, would like to know/ figure out how to fix it.Metal circular piece needed to be malleted down to function as expected." it was also alleged the nail was missed due to inappropriate locking of the sleeve.This situation can be solved while holding the triple-sleeves in desired position and then locking the targeting sleeve as usual with the locking knob.In such a case targeting accuracy is fully given.In this case a real deficiency, because of missing item, could not be confirmed but considering repeated reports of the same matter a relation to the product cannot be excluded.In case further events like this occur, required functional check after re-processing resp.Prior to use will avoid further use.For pin motion a former event had triggered a nc for the current occurrence in the market and is now monitored and executed by the r&d lifecycle management.
Event or Problem Description
It was reported that the sleeve for gamma4 was not working correctly, it wouldn't lock in.24-jan-2024-update.Intra-op-sleeve was not locking to targeting guide.Triple sleeve typically lines into the drill hole for the nail but because the guide was not engage it was going posterior to the nail, and the nail was missed.Had to take off the guides and do perfect circles and complete the surgery free hand.Longer or time 20-25 mins.Metal circular piece needed to be malleted down to function as expected.

• Brand Name: G4 TARGETING SLEEVE
• 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: 18707517
• Report Number: 0009610622-2024-00069
• Device Sequence Number: 20650789
• Product Code: HSB
• UDI-Device Identifier: 07613327479911
• UDI-Public: 07613327479911
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• 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,Followup
• Report Date (Section B): 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 14200110
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 04/29/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male