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

Catalog Number 54-25376S

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2018

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event 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 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.

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
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8081327
• MDR Text Key: 127861611
• Report Number: 0008031020-2018-00984
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540578693
• UDI-Public: 04546540578693
• Combination Product (y/n): N
• PMA/PMN Number: K040022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 54-25376S
• Device Lot Number: 1000304772
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: 11/22/2018
• Supplement Dates FDA Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Weight: 73