MAUDE Adverse Event Report: BIOMET MICROFIXATION EPKER OSTEO 6MM TIP STR CV; OSTEOTOME, GENERAL & PLASTIC SURGERY

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Concomitant medical products: item #01-0406, lot t211680000, epker osteotome 6mm tip straight qty 2; item #01-0408, lot t211240000, epker osteo 6mm tip str cv.Report source¿ foreign: (b)(6).The instruments were not returned for investigation; however, photos were provided.The provided photos confirm the tips of the instruments were chipped.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00577; 0001032347-2021-00594; 0001032347-2022-00038.
Event or Problem Description
It was reported during a procedure that when using the device for opening the upper and lower jaws, the tip was chipped.No medical intervention was required.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Concomitant medical products: item #01-0406, lot t211680000, epker osteotome 6mm tip straight qty 2; item #01-0408, lot t211240000, epker osteo 6mm tip str cv.Report source¿ foreign: (b)(6).The instruments were not returned for investigation; however, photos were provided.The provided photos confirm the tips of the instruments were chipped.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00577; 0001032347-2021-00594; 0001032347-2022-00038.
Event or Problem Description
It was reported during a procedure that when using the device for opening the upper and lower jaws, the tip was chipped.No medical intervention was required.

• Brand Name: EPKER OSTEO 6MM TIP STR CV
• Common Device Name: OSTEOTOME, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: christina arnt ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13578968
• Report Number: 0001032347-2022-00039
• Device Sequence Number: 5644363
• Product Code: HWM
• UDI-Device Identifier: 00841036007768
• UDI-Public: (01)00841036007768(10)T211240000
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N/A
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2022

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: 01-0408
• Device Lot Number: T211240000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2021
• 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
• Patient Sex: Unknown