MAUDE Adverse Event Report: STRYKER GMBH 2.7MM XXL VOLAR DR PLATE, NARROW, RI; PLATE, FIXATION, BONE

Catalog Number	54-25442S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
When the bone screw(2.7mm) was inserted into the screw hole of the plate (54-25442s), the scraped piece was fell.The scraped piece was removed from the patient body and the screw and plate was implanted.The surgeon want to know what foreign matter was scraped.
Event or Problem Description
When the bone screw(2.7mm) was inserted into the screw hole of the plate (54-25442s), the scraped piece was fell.The scraped piece was removed from the patient body and the screw and plate was implanted.The surgeon want to know what foreign matter was scraped.
Additional Manufacturer Narrative
The reported event that 2.7mm xxl volar dr plate, narrow, ri was alleged of 'device stripped/twisted' could be confirmed.Based on the given information, the root cause was attributed to be user related.The failure was caused by possible to much angulation during screw insertion.The device inspection revealed the following: the returned metal swarf / shaving is surely from the implanted plat as it¿s color is gray (t102).As the color of the screws are actually golden.Too much angulation during the screw insertion created a piece of metal swarf / shaving from the plate.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: 2.7MM XXL VOLAR DR PLATE, NARROW, RI
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8121807
• Report Number: 0008031020-2018-01014
• Device Sequence Number: 13764132
• Product Code: HRS
• UDI-Device Identifier: 04546540640932
• UDI-Public: 04546540640932
• Combination Product (Y/N): N
• PMA/510(K) Number: K100271
• 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): 02/26/2019

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 Expiration Date: 05/11/2022
• Device Catalogue Number: 54-25442S
• Device Lot Number: 1000255994
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 12/01/2018
• Supplement Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other