MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM; SCREW, FIXATION, BONE

Catalog Number	656316
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2019
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
It was reported that, during a primary procedure on a right distal radius, after pre-drilling holes, the first locking screw was placed and would not lock.The screw just kept spinning in the plate.A second screw was used in the same hole and locked as intended.This same experience (first screw not locking, second screw locking) happened on additional holes.Surgery was completed successfully with an approximate one minute delay and no adverse consequences.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.Based on investigation, the root cause was attributed to be user related.The failure was caused by the misuse of the product.The visual and functional inspection showed that the screws are fully functional: they are easily locking to the plate.Moreover, the screws are in a good state overall.However, some color fading was noticed.Therefore, some possible root causes that could have led to such an event are, but are not limited to: the use of a large force during the insertion of the device.The use of a large insertion angle than the acceptable value for the position of the screw on the plate.As a reminder, the ifu states: "ensure that you are familiar with the intended uses, indications/ contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.Please remember that product systems may be subject to alterations that affect the compatibility of the implant with other implants or with instruments.For your information, avail yourself of the training courses and publications offered (e.G.Operative techniques).Avoid surface damage of implants.Discard all damaged or mishandled implants." therefore, this case is classified as a user related issue.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.
Event or Problem Description
It was reported that, during a primary procedure on a right distal radius, after pre-drilling holes, the first locking screw was placed and would not lock.The screw just kept spinning in the plate.A second screw was used in the same hole and locked as intended.This same experience (first screw not locking, second screw locking) happened on additional holes.Surgery was completed successfully with an approximate one minute delay and no adverse consequences.

• Brand Name: LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8848094
• Report Number: 0008031020-2019-00974
• Device Sequence Number: 16781154
• Product Code: HWC
• UDI-Device Identifier: 07613327068689
• UDI-Public: 07613327068689
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 10/16/2019

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 Catalogue Number: 656316
• Device Lot Number: 1000235672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1