MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L20MM; SCREW, FIXATION, BONE

Model Number	656320S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "when screwing in a 2.7 dr screw, it did not block and could be turned.Replacement was available." additional information: "yes, it has been pre-drilled.The bone quality was very poor." surgical delay of 2 minutes not longer.No other consequences reported.
Event or Problem Description
As reported: "when screwing in a 2.7 dr screw, it did not block and could be turned.Replacement was available." additional information: "yes, it has been pre-drilled.The bone quality was very poor." surgical delay of 2 minutes not longer.No other consequences reported.
Additional Manufacturer Narrative
Based on the additional information received from the surgeon and stryker representative it was confirmed that only 2 out of 10 screws involved in this event displayed alleged locking issues.The device did not malfunction or contribute to the reported failure and therefore was concluded as concomitant.The device in this mfr# 0008031020-2020-02562 report should not have been reported to the fda.

• Brand Name: LOCKING SCREW,T8 FULL THREAD, 2.7MM/L20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11023903
• Report Number: 0008031020-2020-02562
• Device Sequence Number: 869709
• Product Code: HWC
• UDI-Device Identifier: 07613327070712
• UDI-Public: 07613327070712
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/24/2021

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: 656320S
• Device Catalogue Number: 656320S
• Device Lot Number: 1000349010
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1