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

Model Number	5150-3-070
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that on 15/09 a diaphyseal fracture of the right tibia was treated with a triax blue fixator.At the end of the implantation, during the closure of the standard clamp code 5150-3-070 lot h24962 ((b)(4)) there was a breakage of one of the two nuts of the cover of the clamp that block the chips, with consequent loss of the seal on the chips and therefore of the obtained reduction of the fracture.Not having a second clamp to perform the replacement, the surgeon opted to remove and implant hoffmann 3 fixator.The patient will undergo a first checkup on monday 27/09 at which time they will evaluate the stability and decide whether or not to convert it to unilateral.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported that on (b)(6) a diaphyseal fracture of the right tibia was treated with a triax blue fixator.At the end of the implantation, during the closure of the standard clamp code 5150-3-070 lot h24962 ((b)(6)) there was a breakage of one of the two nuts of the cover of the clamp that block the chips, with consequent loss of the seal on the chips and therefore of the obtained reduction of the fracture.Not having a second clamp to perform the replacement, the surgeon opted to remove and implant hoffmann 3 fixator.The patient will undergo a first checkup on monday (b)(6) at which time they will evaluate the stability and decide whether or not to convert it to unilateral.
Additional Manufacturer Narrative
Corrections: please refer to h6 device code.The reported event could be confirmed, since on screw is broken as reported.Visual inspection: the visual inspection has shown that one of the two screws, of the clamping mechanism for the small pins, is badly damaged/deformed from use.By the other one, we got only a bit of the screw tip thread returned, which is blocked in the blue counterpart, the screw head and shaft got not returned for evaluation.Most likely the breakage is a result from to much force by locking.A disassembling from the broken screw and the blue part is not possible.Furthermore, the blue coating is faded a round the hole and some of the material is deformed from use.Functional inspection: the damaged/deformed screw is still function, the other screw is not functional anymore as it is broken and blocked in the hole.Based on this, as one of the two screws from the locking mechanism is broken, the whole locking mechanism is not functioning anymore.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 user error 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12779301
• Report Number: 0008031020-2021-00450
• Device Sequence Number: 5749519
• Product Code: KTT
• UDI-Device Identifier: 07613327072822
• UDI-Public: 07613327072822
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5150-3-070
• Device Catalogue Number: 51503070
• Device Lot Number: H24962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2021
• 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
• Patient Sex: Unknown