MAUDE Adverse Event Report: STRYKER GMBH 4 HOLE PIN CLAMP, RED MONOTUBE TRIAX Ø 25MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	51503075
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It has been reported that on the (b)(6), the surgeon implanted 2 pin clamp in an patient with achondroplasia, in order to make a femur bilateral enlargement.This was a second procedure.
Additional Manufacturer Narrative
The reported event that the 4 hole pin clamp, red monotube triax ø 25mm were loosen after surgery could be confirmed.Based on the investigation, the root cause was attributed to be user related.The failure was probably caused by over torque of the screws of the clamp.The device inspection revealed that it was found that the screw holes were deformed, making it difficult to insert the screw.Overtorqueing the screw will deform the threaded clamp holes since the clamp material is softer than the screw, although this deformation will only occur if a greater force than normal is applied.Like this it is more difficult for the screw to advance and therefore, the screws will not be properly tighten.Additionally, it was reported that the doctor might have use incorrectly the torque limiter, which is also a cause for the screws to be over torque.Note, as stated in the operative technique (mt-st-3-en monotube triax op tech): ¿note: all square head screws need to be tightened to the appropriate torque to maintain adequate stability using the torque wrench.[¿] locking the fixator once an anatomical reduction is achieved, lock the fixator in all planes.The torque wrench should be used after initial tightening to assure all clamps are locked properly.For the red system, this helps ensure the components are tightened to 11nm; for the blue system 9nm; and for the yellow 5nm.Use of monotube torque wrench proper use of the torque wrench is important.Make sure the torque wrench head is fully seated over the clamp screw.Grip the end of the wrench handle, keeping the thumb in a ¿fist¿ position.Tighten the clamp screw only until the silver torque wrench bar contacts the color coded handle.When the bar and the wrench handle come in contact, the clamp screw has been tightened to the recommended maximum torque.Improper placement of the thumb can change the torque level achieved by the wrench.This may result in under tightening of the screws on the clamp.Note: do not over tighten as this may damage the clamp or torque wrench.'' [original statement(s)].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
It has been reported that on the (b)(6), the surgeon implanted 2 pin clamp in an patient with achondroplasia, in order to make a femur bilateral enlargement.This was a second procedure.Additional information: some weeks later during the follow up, it is detected that the enlargement of one of the femurs is not effective because one of the pin clamps seems to have been loosened.The surgeon claims that all the screws of the pin clamps were properly tighten during the procedure.On the (b)(6), the surgeon explants both pin clamps and swaps them for 2 of the same items.

• Brand Name: 4 HOLE PIN CLAMP, RED MONOTUBE TRIAX Ø 25MM
• 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: 6185342
• Report Number: 0008031020-2016-00604
• Device Sequence Number: 970102
• Product Code: KTT
• UDI-Device Identifier: 07613327072839
• UDI-Public: (01)07613327072839(10)V21208
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2017

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: 51503075
• Device Lot Number: V21208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 04/17/2017
• 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: Required Intervention