MAUDE Adverse Event Report: STRYKER GMBH 2.3 M VARIAX HAND LOCK Z-PLATE,NAR,13HOLES; PLATE, FIXATION, BONE

Model Number	57-15379
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	03/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; hospital retained.
Event or Problem Description
As reported: "plate was used for a mp finger fusion.Second time plate has broken on same patient.Doctor removed broken hardware and put in competitor hand plate.".
Event or Problem Description
As reported: "plate was used for a mp finger fusion.Second time plate has broken on same patient.Doctor removed broken hardware and put in competitor hand plate.".
Additional Manufacturer Narrative
The reported event that 2.3 m variax hand lock z-plate, nar, 13 holes was alleged of "implant - breakage post-operative" could be confirmed only based on pictures.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.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: 2.3 M VARIAX HAND LOCK Z-PLATE,NAR,13HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9954495
• Report Number: 0008031020-2020-01267
• Device Sequence Number: 14155158
• Product Code: HRS
• UDI-Device Identifier: 07613154496730
• UDI-Public: 07613154496730
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K062498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2020

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 Model Number: 57-15379
• Device Catalogue Number: 57-15379
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 06/15/2020
• 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: 53 YR