MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BIT T15, AO FITTING; PLATE, FIXATION, BONE

Model Number	705015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/01/2018
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
It was reported that during an axsos proximal humerus case, the screwdriver bit which is attached to the torque limiting adaptor was used to insert the screw by hand.Prior to achieving 2.5nm torque, the tip of the screwdriver broke off.It was reported that the broken tip remained inside the screw-head.It was reported that the screw was left in the patient.
Additional Manufacturer Narrative
The reported event that screwdriver bit t15, ao fitting was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by to much applied mechanical force during screw insertion.The device inspection revealed the following: the returned screwdriver bit is indeed completely broken off.The close up of the fracture surface show some cracks (see attached image documentation) whereas the high applied forces led to a strain hardening / embrittlement of the material which finally resulted in the breakage.The root cause of the failure was repeated powerful dynamically overload during use.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 was reported that during an axsos proximal humerus case, the screwdriver bit which is attached to the torque limiting adaptor was used to insert the screw by hand.Prior to achieving 2.5nm torque, the tip of the screwdriver broke off.It was reported that the broken tip remained inside the screw-head.It was reported that the screw was left in the patient.

• Brand Name: SCREWDRIVER BIT T15, AO FITTING
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7481055
• Report Number: 0008031020-2018-00337
• Device Sequence Number: 13860553
• Product Code: HRS
• UDI-Device Identifier: 07613327091649
• UDI-Public: (01)07613327091649
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141121
• 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): 08/08/2018

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: 705015
• Device Catalogue Number: 705015
• Device Lot Number: K046F74
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 08/08/2018
• 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