MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PRESSURE SENTINEL INTRAMEDULLARY SYSTEM FLEXIBLE REAMER LONG; INSTRUMENT, SURGICAL, ORTHOPEDIC ACCESSORIES/ATTACHMENTS

Catalog Number	00221801200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - the event occurred in canada.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that 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 an intramedullary tibia nail procedure, the long flexible reamer fractured after applying a suprapatellar nailing technique and reaching a point of resistance in the diaphysis.The surgeon retrieved all pieces of the reamer and then pulled the reamer out by hand to insert the nail.No additional complications were reported as a result of this malfunction.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: proposed annex g code - mechanical (g04) - drill.The reported event is confirmed by provided photos.Visual examination of the provided pictures identified the shaft of the device is fractured.A review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: PRESSURE SENTINEL INTRAMEDULLARY SYSTEM FLEXIBLE REAMER LONG
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC ACCESSORIES/ATTACHMENTS
• 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: 20355817
• Report Number: 0001822565-2024-03166
• Device Sequence Number: 8086291
• Product Code: HWE
• UDI-Device Identifier: 00889024038523
• UDI-Public: (01)00889024038523(10)63659802
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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: 00221801200
• Device Lot Number: 63659802
• 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: 09/09/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2017
• 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
• Patient Age: 18 YR
• Patient Sex: Unknown