MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L32MM; SCREW, FIXATION, BONE

Catalog Number	656432
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.It is reported that ¿no further information will be released by the hospital or surgeon¿.If the device is returned or if any additional information is provided, the investigation will be reassessed.Head of screw was lost at hospital; rest of screw remains implanted.
Event or Problem Description
Primary lisfranc procedure, right foot.It was reported that when the non-locking screw was seated in the plate, the surgeon was using the screw to compress the fracture when the head of the screw broke off.The screw head was able to be retrieved, the rest of the screw was left in the patient.Another screw was implanted under the previous screw.Surgery was completed successfully with a delay of approximately 2 minutes.No adverse consequences reported.

• Brand Name: BONE SCREW, T8 FULL THREAD, 2.7MM/L32MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9010990
• Report Number: 0008031020-2019-01276
• Device Sequence Number: 14100304
• Product Code: HWC
• UDI-Device Identifier: 07613327068986
• UDI-Public: 07613327068986
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/12/2019

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: 656432
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR