MAUDE Adverse Event Report: BIOMET MICROFIXATION EPKER OSTEOTOME 6MM TIP STRAIG

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Concomitant medical products: item # 01-0408, lot # t21343000; epker osteo 6mm tip str cv.Item # 01-0401, lot # t22094000; epker osteotome 4mm tip straig.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2022-00383 and 0001032347-2022-00390.
Event or Problem Description
It is reported that the blade had a chip in it the first time it was used.A different instrument was used to complete the procedure.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information is needed at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned.A visual inspection was conducted on the customer provided photo.The photo shows a total of three instruments where the tips of the instruments are all slightly chipped.For all three instruments the complaint is confirmed.A determination cannot be made as to what caused the tips to chip.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in section b4, b5, d4, g3, g6, h2, h3, h4, h6 and h10.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: EPKER OSTEOTOME 6MM TIP STRAIG
• Common Device Name: OSTEOTOME
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15971248
• Report Number: 0001032347-2022-00391
• Device Sequence Number: 5526212
• Product Code: HWM
• UDI-Device Identifier: 00841036007744
• UDI-Public: (01)00841036007744(10)T213430001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2023

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 Model Number: N/A
• Device Catalogue Number: 01-0406
• Device Lot Number: K21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 03/10/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/11/2023; 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Unknown