MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L16MM; SCREW, FIXATION, BONE

Catalog Number	656416
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event that bone screw, t8 full thread, 2.7mm/l16mm was alleged of 'breakage during surgery' could be confirmed based on the picture received.Based on investigation, the root cause was attributed to be user related.The failure was caused by possible too much applied torsional force during screw insertion.Nevertheless more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event, unfortunately no additional information were available due to hospital policy.A review of the device history was not possible because the lot number was not communicated.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Primary procedure, left distal radius.It was reported that a 2.7 x 16 bone screw broke at the head during insertion.The head was removed, the portion in the patient's bone was left in and another screw hole was used to complete the procedure with a surgical delay of less than 1 minute reported.Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.

• Brand Name: BONE SCREW, T8 FULL THREAD, 2.7MM/L16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8162198
• Report Number: 0008031020-2018-01055
• Device Sequence Number: 13817840
• Product Code: HWC
• UDI-Device Identifier: 07613327068856
• UDI-Public: 07613327068856
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K180500
• 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
• Report Date (Section B): 12/13/2018

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 Catalogue Number: 656416
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/13/2018
• 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
• Patient Age: 50 YR