MAUDE Adverse Event Report: STRYKER GMBH G4 TROCH NAIL D10XL170MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 81250170S

Device Problem Device Damaged by Another Device (2915)

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

Event Date 01/04/2024

Event Type  malfunction  

Event Description

As reported: "g4 intermediate nail miss drill was occurred on lateral side during drilling of distal dynamic hole.Pre-calibration showed correct targeting.The cortical bone and nail were in contact at the lateral end, and the physician determined that the miss drill was due to loading on the nail.".

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 remains implanted in the patient.

Manufacturer Narrative

Please note corrections to: d1 / product long description, d4 / catalog#, d4 / gtin#, g4 / 510k# the reported event could not be confirmed since the device was not returned for evaluation and no other evidences was provided.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.Based on the available information did the affected devices pass the intra-operative function test before insertion and also the post-operative function test as the instruments are continued to be used.Therefore, a product related issue can be excluded and the event was most likely use related, which is also indicated by statement in the event description that there was possibly to much load on the nail.If more information is provided, the case will be reassessed.

Event Description

As reported: "g4 intermediate nail miss drill was occurred on lateral side during drilling of distal dynamic hole.Pre-calibration showed correct targeting.The cortical bone and nail were in contact at the lateral end, and the physician determined that the miss drill was due to loading on the nail.".

• Brand Name: G4 TROCH NAIL D10XL170MM X 125DEG
• 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: 18620127
• MDR Text Key: 334495622
• Report Number: 0009610622-2024-00049
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327479058
• UDI-Public: 07613327479058
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K213328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 81250170S
• Device Lot Number: K1776E5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 50 KG