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	08/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.
Event or Problem Description
The plate was broken due to place her hand after 8 week later from initial surgery.
Event or Problem Description
The plate was broken due to place her hand after 8 week later from initial surgery.
Additional Manufacturer Narrative
The reported event that 2.3 m variax hand lock t-plate,narrow,6holes was alleged of 'implant breakage after surgery' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Note that due to the hospital policy, no additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.As indicated ¿ the plate was broken due to place her hand after 8 week later from initial surgery¿, therefore the plate breakage was most likely patient related.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• 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: 7907948
• Report Number: 0008031020-2018-00637
• Device Sequence Number: 1449826
• 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): 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/19/2023
• Device Catalogue Number: 57-15340S
• Device Lot Number: 1000295613
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/04/2018
• 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: Required Intervention