MAUDE Adverse Event Report: STRYKER GMBH VOLAR SMARTLOCK DISTAL RADIUS PLATE, STANDARD, LEFT,SHORT, 11 HOLES; PLATE, FIXATION, BONE

Catalog Number	54-25376S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2018
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
Implanting of the plate using variaxdr with left radial distal end fracture osteosynthesis.When confirming with the image before the suture, since it was two pieces remained like metal pieces near the proximity from the plate installation position, it was collected out of patient body.Checked the variaxdr's instruments and drills used in the ope, but not find the instrument damage.It was confirmed that the tip of the hospital-owned kochel forceps is missing, but can not specify whether this is kochel forceps or implant fragments.
Event or Problem Description
Implanting of the plate using variaxdr with left radial distal end fracture osteosynthesis.When confirming with the image before the suture, since it was two pieces remained like metal pieces near the proximity from the plate installation position, it was collected out of patient body.Checked the variaxdr's instruments and drills used in the ope, but not find the instrument damage.It was confirmed that the tip of the hospital-owned kochel forceps is missing, but can not specify whether this is kochel forceps or implant fragments.
Additional Manufacturer Narrative
Investigation revealed the subject product to be a concomitant item.The device did not contribute to the reported event.Note that plate is still implanted and forceps which is actually broken off is not even a stryker product at all.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

• Brand Name: VOLAR SMARTLOCK DISTAL RADIUS PLATE, STANDARD, LEFT,SHORT, 11 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8081327
• Report Number: 0008031020-2018-00984
• Device Sequence Number: 16475474
• Product Code: HRS
• UDI-Device Identifier: 04546540578693
• UDI-Public: 04546540578693
• Combination Product (Y/N): N
• PMA/510(K) Number: K040022
• 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): 12/18/2018

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: 54-25376S
• Device Lot Number: 1000304772
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 12/18/2018
• 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
• Patient Age: 81 YR
• Patient Weight: 73