MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE REAMER 5.0 MM DIAMETER; INSTRUMENT, SURGICAL

Model Number	2228-05
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign- austria.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: 0001822565 - 2023 - 01962.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 that during a hip procedure, the drill got stuck while trying to drill back out, and the tip of both drills broke off.Both the fractured tips are retained in the patient body.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were corrected: d4 (udi#).Proposed component code: mechanical (g04) - drill.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified two pressure sentinel intramedullary flexible reamers were returned.As returned, both devices are missing the reamer head. the flexible shafts are not fractured. a finished end is seen on both shafts.Device history record (dhr) was reviewed and no discrepancies were found.As the user did not utilize a guide wire during the procedure to ensure proper guidance and allow for capturing of the fractured reamer head, the root cause of the reported issue is attributed to use error for not following instructions.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
No further event information is available at the time of this report.

• Brand Name: FLEXIBLE REAMER 5.0 MM DIAMETER
• Common Device Name: INSTRUMENT, SURGICAL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17349832
• Report Number: 0001822565-2023-01961
• Device Sequence Number: 6091644
• Product Code: HWE
• UDI-Device Identifier: 00889024038714
• UDI-Public: (01)00889024038714(11)210601(10)65151149
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2023

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: 2228-05
• Device Catalogue Number: 00222800500
• Device Lot Number: 65151149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 00222800600 65157016 FLEXIBLE REAMER 6.0 MM.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown