MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0MM SYSTEM TWIST DRILL WITH J NOTCH 1.5 X 50MM, 7MM STOP; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	N/A
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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: 0001032347-2020-00257.Concomitant medical products: 1.5mm system twist drill with j notch 1.1 x 50mm, 5mm stop, part# 01-7142, lot# unk; 2.0mm system twist drill with j notch 1.5 x 50mm, 7mm stop, part# 01-9193, lot# unk.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source - (b)(6).
Event or Problem Description
It was reported the patient retained a foreign body after paint flaked off of drill bits.After drilling the holes, the surgeon noted the paint on the drill bits was missing.Some but not all of the peeled paint was located in the suction tank.No additional patient consequences have been reported.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed.The two twist drills were visually evaluated and found to show signs of use.Neither twist drill appeared to have the appropriate color band per the prints.The non-conformance database was reviewed for these products; no non-conformances were found.There are no indications of manufacturing defects.This is the only complaint regarding the paint peeling off for this item# 01-9193, vendor lot# 341462.The most likely underlying cause of the complaint could not be determined.It is possible that the paint peeled off as a result of improper cleaning and sterilization or being reused.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.The following fields were updated: date of this report; describe event or problem; device availability; date received by manufacturer; type of report; follow up type; device evaluated by manufacturer; method code; results code; conclusions code; additional narratives/data.

• Brand Name: 2.0MM SYSTEM TWIST DRILL WITH J NOTCH 1.5 X 50MM, 7MM STOP
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10115403
• Report Number: 0001032347-2020-00258
• Device Sequence Number: 13893863
• Product Code: HBE
• UDI-Device Identifier: 00841036016937
• UDI-Public: 00841036016937
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2020

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-9193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/31/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 08/04/2020
• 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: Required Intervention