MAUDE Adverse Event Report: STRYKER GMBH TEMPORARY PLATE FIXATOR AXSOS 3 TI AO FITTING; PLATE, FIXATION, BONE

Catalog Number 705019

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2016

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that surgeon was using the axsos3 5mm system.The consultant used the temporary plate fixator ((b)(4)) in the shaft of the bone.As he was drilling into the bone he felt it was bending so withdrew the instruments and then realised the end had snapped off, remaining in the patient's bone.

Manufacturer Narrative

The reported incident that the tip of the ¿temp.Plate fixator pin ao fitting¿ snapped off, remaining in the patient¿s bone, when the consultant was drilling into the shaft of the bone (s-11 / breakage during surgery) could be confirmed, since the device was returned for evaluation and it matches the reported failure mode.The device was received, for evaluation, broken at the tip.The inspection revealed that apart from the broken tip, the surface of the pin does not have any significant scratches.This is compatible with what has been reported: that ¿the stated device was brand new and the first time the set has been used, was during the reported incident.¿ the threaded tip is broken, almost at the end, while the breakage surface shows signs of torsional deformation.The pin was most likely twisted under high loads and eventually broke.As per op.Tech.(axsos3_2015-7178): ¿to help prevent thermal necrosis during the drilling stage, it is recommended that the temporary plate fixator pin is inserted by hand.¿ in case excessive torque was used during the drilling process, such power, in combination with hard/dense bone, and even violent moves, could definitely deform the pin and lead to such a breakage.Particularly, if the drilling was in an inclined angle, in the hard bone, a bending moment could be generated, leading to a fracture, as the one reported.This aligns with the reported incident description, that ¿the consultant felt that the pin was bending¿.As per ifu (v15011): ¿ensure that you are familiar with the recommended uses, compatibility and correct handling of the instrument.[¿] only use an instrument for its intended purpose.Improper use of instruments might lead to loss in function or usage.[¿] always treat the instrument carefully to avoid surface damage or alterations to the instrument geometry.¿ based on the investigation the case could be classified as user-related due to over-torque.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 Description

It was reported that surgeon was using the axsos3 5mm system.The consultant used the temporary plate fixator (705019) in the shaft of the bone.As he was drilling into the bone he felt it was bending so withdrew the instruments and then realised the end had snapped off, remaining in the patient¿s bone.

• Brand Name: TEMPORARY PLATE FIXATOR AXSOS 3 TI AO FITTING
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5890806
• MDR Text Key: 53465245
• Report Number: 0008031020-2016-00395
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K141121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 705019
• Device Lot Number: 03553J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other