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 Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
When attaching the tube to the pin holder, the pin holder broke off.Replacement was available.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on the investigation, the root cause was determined to be user related.The failure was caused by an over torque applied on the clamp square head screw.The device inspection revealed that the screw is indeed broken.The screw breakage surface is consistent with a fracture due to over torqueing.The operative technique guide clearly mentions not to overtighten the screws as they might get damage along with the torque wrench.It is unknown if a torque wrench was used, however it is strongly recommended to manipulate the screws with this instrument as it will give an indication of when the appropriate torque is reached.If such instrument is not used, it is likely that the square head screw will break under too much torque.Note as stated in the operative technique guide: ''note: all square head screws need to be tightened to the appropriate torque to maintain adequate stability using the torque wrench.[¿] note: do not overtighten as this may damage the clamp or torque wrench.'' 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.If any further information is provided, the investigation report will be updated.
Event or Problem Description
When attaching the tube to the pin holder, the pin holder broke off.Replacement was available.

• 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 ; CH 2545
• MDR Report Key: 8501932
• Report Number: 0008031020-2019-00351
• Device Sequence Number: 2594296
• Product Code: KTT
• UDI-Device Identifier: 07613327072822
• UDI-Public: 07613327072822
• Combination Product (Y/N): N
• PMA/510(K) Number: K910483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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 Catalogue Number: 51503070
• Device Lot Number: Y52705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other