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	Failure of Implant (1924)
Date of Event	05/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that on (b)(6) 2019, fixation was done with variax hand plate for arthrosis of cm joint of thumb.After operation, the plate was broken and revision surgery was done on (b)(6) 2019 with new plate.
Event or Problem Description
It was reported that on (b)(6) 2019, fixation was done with variax hand plate for arthrosis of cm joint of thumb.After operation, the plate was broken and revision surgery was done on (b)(6) 2019 with new plate.
Additional Manufacturer Narrative
The reported event could be confirmed, unfortunately no further details / x-rays have been made available in order to determine the exact cause despite multiple attempts.Based on investigation, the root cause was attributed to be likely patient related.The failure was caused by powerful dynamically overload of the fracture area of the plate.The device inspection revealed the following: the returned variax hand plate was broken.(which was noticed during the follow up visit).The investigation shows that the plate broke in low cycle fatigue mode by exceeding the material strength after a few cycles under partially very high forces.The fracture surfaces reveal partially predominant proportions of forced rupture, material embrittlement and secondary cracks as well as swinging lines of a fatigue breakage to some extent.The root cause of the failure could have been one or repeated powerful dynamically overload of the fracture area of 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.
Additional Manufacturer Narrative
Correction: sections d1, d4, gtin, h4.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.
Event or Problem Description
It was reported that on(b)(6)2019, fixation was done with variax hand plate for arthrosis of cm joint of thumb.After operation, the plate was broken and revision surgery was done on (b)(6)2019 with new plate.

• 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: 8709674
• Report Number: 0008031020-2019-00677
• Device Sequence Number: 2662971
• Product Code: HRS
• UDI-Device Identifier: 04546540542304
• UDI-Public: 04546540542304
• Combination Product (Y/N): N
• PMA/510(K) Number: K062498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2019

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: 08/01/2023
• Device Catalogue Number: 57-15340S
• Device Lot Number: 1000315375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 07/25/2019; 09/26/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 08/21/2019; 10/03/2019
• 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: Required Intervention
• Patient Age: 62 YR