MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T10 FULL THREAD, 2.7MM/L14MM; SCREW, FIXATION, BONE

Model Number	657114S
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2020
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 the variax screw (657114s) was inserted into the plate, it did not bite the bone and the screw slipped.This was a cortical screw, which had firmly engaged the opposite cortical bone on the image.I managed to fix it with an alternative screw (657414s).The procedure was terminated with unknown cause.There was no problem with the screw length.".
Event or Problem Description
As reported: "when the variax screw (657114s) was inserted into the plate, it did not bite the bone and the screw slipped.This was a cortical screw, which had firmly engaged the opposite cortical bone on the image.I managed to fix it with an alternative screw (657414s).The procedure was terminated with unknown cause.There was no problem with the screw length.".
Additional Manufacturer Narrative
Correction: refer to d10, h3 device availability the reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.However, based on the event description, the reference 657114s refers to a 2.7 mm screw, while the reference 657414s refers to a 3.5 mm screw.It should be noted that the diameters are different, and that it is the 3.5 that bit into the bone.It is possible that a 3.2 mm hole was drilled and not a 2.5 mm, resulting in the 3.5 mm screw fitting into the hole rather than the 2.7mm.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.More information is needed in order to determine the root cause of the event.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device discarded.

• Brand Name: BONE SCREW, T10 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: 9845751
• Report Number: 0008031020-2020-00734
• Device Sequence Number: 2886360
• Product Code: HWC
• UDI-Device Identifier: 07613327071535
• UDI-Public: 07613327071535
• Combination Product (Y/N): N
• 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): 05/21/2020

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: 04/08/2024
• Device Model Number: 657114S
• Device Catalogue Number: 657114S
• Device Lot Number: 1000350230
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1