MAUDE Adverse Event Report: BIOMET MICROFIXATION TW DRILL 1.5X50MM 10MMSTP W/NT; INSTRUMENT, MICROFIXATION

Catalog Number	01-9195
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported approximately three (3) weeks ago, that the instrument broke when nailing during a surgery that occurred approximately two (2) years and six (6) months ago.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported device was returned for evaluation.The tip of the drill bit is fractured and was not returned.No further evaluation possible.The device has a potential field age of approximately two years.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The supplier dhr was not requested as the coc confirms material conformance and the device has a potential field of approximately 2 years.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TW DRILL 1.5X50MM 10MMSTP W/NT
• Common Device Name: INSTRUMENT, MICROFIXATION
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11640674
• Report Number: 0001032347-2021-00191
• Device Sequence Number: 3160034
• Product Code: HBE
• UDI-Device Identifier: 00841036016951
• UDI-Public: (01)00841036016951
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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 Catalogue Number: 01-9195
• Device Lot Number: 003100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 09/15/2021
• 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: NI
• Patient Sequence Number: 1