MAUDE Adverse Event Report: STRYKER GMBH 2.3 M VARIAX HAND LOCK T-PLATE,NARROW,6HOLES; PLATE, FIXATION, BONE

Catalog Number	57-15340S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2018
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
An unknown day, implanted the variax hand.Since bone fusion was obtained, so attempted to remove the variax hand.Only one locking screws could not be removed, and the plate was pulled out with the locking screw.The physician requested us why the locking screw could not be pulled out.
Additional Manufacturer Narrative
The reported event that 2.3 m variax hand lock t-plate,narrow,6holes was alleged of 'component/device stuck' could be confirmed.Based on investigation, the root cause was attributed to be other related.The failure was caused possibly by too much force during screw insertion / locking.The device inspection revealed the following: both returned parts (plate & screw) are indeed completely stuck and still locked well in position.The cross pin head is indeed completely damaged and marks at and below the locking threads are indicating that that extra force may have been applied during screw insertion / locking.The damages / deformations of the screw head enabled to get the screw out if it¿s locking position.It looks like that the screw was locked in position with too much force and possibly caused a problem during removal or the screwdriver tip was not in working order.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 any further information is provided, the investigation report will be updated.
Event or Problem Description
An unknown day, implanted the variax hand.Since bone fusion was obtained, so attempted to remove the variax hand.Only one locking screws could not be removed, and the plate was pulled out with the locking screw.The physician requested us why the locking screw could not be pulled out.

• Brand Name: 2.3 M VARIAX HAND LOCK T-PLATE,NARROW,6HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7756992
• Report Number: 0008031020-2018-00550
• Device Sequence Number: 192093
• Product Code: HRS
• UDI-Device Identifier: 04546540542274
• UDI-Public: 04546540542274
• Combination Product (Y/N): N
• PMA/510(K) Number: K062498
• 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): 09/20/2018

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: 57-15340S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 09/20/2018
• 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