MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PRESSURE SENTINEL FLEXIBLE REAMER 6.0 MM DIAMETER; INSTRUMENT, SURGICAL, ORTHOPEDIC

Catalog Number	00222800600
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an initial elbow procedure, the flexible reamer instrument fractured.The broken drill head was unable to be removed and the surgeons opted to leave the fragment in place as it did not interfere with the implant placement.Due diligence is in progress for this event; to date no additional information has been reported.
Additional Manufacturer Narrative
(b)(4).G2: foreign: germany customer has indicated that the fragmented product is in process of being returned to zimmer biomet for investigation.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical (g04) - drill.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: metallic fragment noted within the proximal to mid diaphysis of the ulna likely represents hardware fragment.Root cause for the instrument fracture was unable to be determined.It was indicated that a ball tip or tear drop guidewire as indicated for use in the ifu were not used as they were not available for the surgery.A k-wire with no tip was used.This lead to the reamer tip not being able to be removed from the patient when the device fractured.However, this off label use is not the root cause of the reported fracture.The reported event was confirmed through the provided x-rays.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.
Event or Problem Description
No further event information at time of this report.

• Brand Name: PRESSURE SENTINEL FLEXIBLE REAMER 6.0 MM DIAMETER
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC
• 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: 20602824
• Report Number: 0001822565-2024-03472
• Device Sequence Number: 7393546
• Product Code: HWE
• UDI-Device Identifier: 00889024038738
• UDI-Public: (01)00889024038738(10)65609787
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/06/2025

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 Catalogue Number: 00222800600
• Device Lot Number: 65609787
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female