MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, T10 FULL THREAD, 2.7MM/L16MM; SCREW, FIXATION, BONE

Model Number	657016
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported that a package of locking variaax 2 screws (657016) contained non-locking screws.
Additional Manufacturer Narrative
D9 / h3 updated to indicate device was returned.The reported event could be confirmed, since the returned packages and screws do not match.The visual inspection has shown that both packages were received in opened condition, also the blister in the bag was opened and the cover of the blister was not returned.Both packages have the catalog number 657016 with lot 1000457593, while both received screws have the catalog number 657116 with lot 1000455299.It can visually be confirmed that both screws are bone screws as the ¿dot¿ and ¿ring¿ marking of a locking screw is missing.A review of the device history for the reported lot and as well of the screw 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.Based on investigation, the root cause was attributed to a use related issue.The failure was most likely caused by a mix-up after the packages were opened.The review of the erp data has shown that the affected lot numbers 1000457593 and 1000455299 were not processed together during the manufacturing process.The lot 1000455299 was released on 29.June 2021 and all parts of this lot number were distributed from the stock on the same day.The production of lot 1000457593 started on 14.July 2021, two weeks after the last part of lot 1000455299 has left the stock.Based on this finding a mix-up during the production of these devices can be excluded.The review of the erp system has also shown that devices of both affected lot numbers were shipped to italy.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that a package of locking variaax 2 screws (657016) contained non-locking screws.

• Brand Name: LOCKING SCREW, T10 FULL THREAD, 2.7MM/L16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 12377599
• Report Number: 0008031020-2021-00383
• Device Sequence Number: 11784842
• Product Code: HWC
• UDI-Device Identifier: 07613327069297
• UDI-Public: 07613327069297
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K180500
• 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): 10/14/2021

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: 657016
• Device Catalogue Number: 657016
• Device Lot Number: 1000457593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1