MAUDE Adverse Event Report: ZIMMER GMBH ANKLE FIX TI-PLATE STANDARD, LEFT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: phoenix ankle fusion nail; catalog#unknown; lot#unknown therapy date: (b)(6) 2019.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on the left side and underwent revision due to implant fracture.
Event or Problem Description
Please refer to report 0009613350 - 2019 - 00385.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available, an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
No change to previously reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Additional: d10, h2, h6.Correction: b4, g4, g7, h10.Event summary: it was reported that the product has been implanted on (b)(6) 2018 and revised on (b)(6) 2019 due to implant fracture.The patient missed all the follow up appointments and come back a year later with the plate fractured and a non union.She stated she was in a fight and fell.Surgeon then used a phoenix im fusion nail to revise non union.Review of received data: no further due diligence required as all required information to support the conclusion is available/was already requested.There are some x-ray pictures available which are displayed on a screen.The x-rays confirm the breakage of the ankle fix plate.Devices analysis: visual examination: the broken ankle fix plate and screws were returned for investigation.The plate was broken into two parts.The fracture of the plate is located through two screw holes.The fracture surfaces are shiny polished and damaged.There are also damages on the thread available from the screws.Several scratches are visible on the surface of the plate.Review of product documentation: all involved devices are intended for treatment.Conclusion summary: it was reported that the product has been implanted on (b)(6) 2018 and revised on (b)(6) 2019 due to implant fracture.The patient missed all the follow up appointments and come back a year later with the plate fractured and a non union.She stated she was in a fight and fell.Surgeon then used a phoenix im fusion nail to revise non union.The visual examination of the plate shows a fracture.The plate is highly damaged.The fracture surfaces are shiny polished.It was mentioned that there was a non union.It is possible that the non union and the fell of the patient lead to the fracture of the ankle fix plate.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The investigation results did not identify a non-conformance or a complaint out of box (coob).The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: ANKLE FIX TI-PLATE STANDARD, LEFT
• Common Device Name: ANKLE FIX TI-PLATE
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8699272
• Report Number: 0009613350-2019-00385
• Device Sequence Number: 1942095
• Product Code: HRS
• UDI-Device Identifier: 00889024107755
• UDI-Public: 00889024107755
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 07/13/2020

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: N/A
• Device Catalogue Number: 28.14.101
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 07/17/2019; 07/06/2020
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 08/08/2019; 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 31 YR