MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L22MM; SCREW, FIXATION, BONE

Model Number	656322
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2019
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
Customer reported that: "when performing osteosynthesis of the lower end of the right radius, the locked screw dia 2.7 lg 22 mm.Did not lock into the plate.''.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences was provided despite multiple attempts.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.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.H3 other text : device disposition unknown.
Event or Problem Description
Customer reported that : "when performing osteosynthesis of the lower end of the right radius, the locked screw dia 2.7 lg 22mm did not lock into the plate".
Event or Problem Description
Customer reported: "when performing osteosynthesis of the lower end of the right radius, the locked screw dia 2.7 lg 22mm did not lock into the plate." additionally reported: event identified per-operative.Procedure completed successfully.No other medical intervention.Delay 30min.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the locking section and the t8 drive of the screw head are indeed completely damaged / deformed.The screw thread from the middle to the tip is still in good shape, only slight wear is visible.Note that the locking mechanism is damaged that severe that it is not working anymore.Based on investigation, the root cause was attributed to be user related.The failure was caused by possible inadequate screw insertion / locking.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 any further information is provided, the investigation report will be updated.

• Brand Name: LOCKING SCREW,T8 FULL THREAD, 2.7MM/L22MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8784460
• Report Number: 0008031020-2019-00822
• Device Sequence Number: 1904548
• Product Code: HWC
• UDI-Device Identifier: 07613327068719
• UDI-Public: 07613327068719
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2020

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 Model Number: 656322
• Device Catalogue Number: 656322
• Device Lot Number: 1000342206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 08/12/2019; 01/23/2020
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 09/06/2019; 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1