MAUDE Adverse Event Report: STRYKER GMBH 4 HOLE PIN CLAMP, BLUE MONOTUBE TRIAX Ø 20MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	51503070
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a im nail tibia with limb lengthening using t2 tibial nail and monotube.It was further reported that patient presented himself at clinic today on (b)(6) 2024 and allegedly claimed the monotube broke.A new monotube was applied in the clinic on (b)(6) 2024.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the patient had a im nail tibia with limb lengthening using t2 tibial nail and monotube.It was further reported that patient presented himself at clinic today on (b)(6) 2024 and allegedly claimed the monotube broke.A new monotube was applied in the clinic on (b)(6) 2024.
Additional Manufacturer Narrative
The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination of the received product shows that the instrument has visible usage marks.Quality assurance engineering reviewed the received information and noted: product investigation: the screw was tightened too hard so that it seized on the helicoil.This meant that when the screw was unscrewed (loosened), the helicoil was pulled out and destroyed.Conclusion: based on these facts, it can be strongly assumed that in both cases lot y56016 and y15062, excessive force was exerted on the screws, which led to fatigue fracture of the screw and unscrewing of the helicoil.The failure of the component is not due to the manufacture, assembly, or material error, but most likely to the patient and the user.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 investigation, the root cause was attributed to a use related issue.The failure was caused most likely by to much force.If more information is provided, the case will be reassessed.

• Brand Name: 4 HOLE PIN CLAMP, BLUE MONOTUBE TRIAX Ø 20MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18708330
• Report Number: 0008031020-2024-00100
• Device Sequence Number: 7070288
• Product Code: KTT
• UDI-Device Identifier: 07613327072822
• UDI-Public: 07613327072822
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K910483
• 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): 05/15/2024

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: Lay User/Patient
• Device Catalogue Number: 51503070
• Device Lot Number: Y15062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2018
• 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: Unknown