MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L14MM; SCREW, FIXATION, BONE

Model Number	656414S
Medical Device Problem Codes	Device Damaged by Another Device (2915); Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available for return, device is still implanted.
Event or Problem Description
The surgeon reported that the screw was inserted ok but on tightening it could not be tightened a much as the surgeon wanted, neither could the screw be removed.The surgeon noted damage to the end of the screw, which is likely to have occurred during tightening.
Event or Problem Description
The surgeon reported that the screw was inserted ok but on tightening it could not be tightened a much as the surgeon wanted, neither could the screw be removed.The surgeon noted damage to the end of the screw, which is likely to have occurred during tightening.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: BONE SCREW, T8 FULL THREAD, 2.7MM/L14MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9721935
• Report Number: 0008031020-2020-00470
• Device Sequence Number: 355731
• Product Code: HWC
• UDI-Device Identifier: 07613327070873
• UDI-Public: 07613327070873
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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,Followup
• Report Date (Section B): 03/31/2020

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 Expiration Date: 04/17/2023
• Device Model Number: 656414S
• Device Catalogue Number: 656414S
• Device Lot Number: 1000297294
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1