MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEPHALOMEDULLARY TARGETING GUIDE STANDARD; ORTHOPAEDIC PROSTHESIS IMPLANTATION POSITIONING INSTRUMENT, REUSABLE

Catalog Number	00249000300
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cm nail jig missed the distal holes upon screw insertion in spite of ensuring the holes were all aligned prior.It is currently unknown what caused the misalignment.A free hand technique was used to insert the screws.Attempts have been made and additional information on the reported event is unavailable at this time.
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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h11 visual examination of the returned device identified damage is seen on the barrel.The device exhibits wear & tear that indicates repeated use during a potential field age greater than 5 years.Product identifiers are conforming to print specifications.Further analysis was not performed as the device was manufactured according to an approved cmm and wear and tear is noted on the device that is consistent with previous use.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The reported event could not be confirmed.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: CEPHALOMEDULLARY TARGETING GUIDE STANDARD
• Common Device Name: ORTHOPAEDIC PROSTHESIS IMPLANTATION POSITIONING INSTRUMENT, REUSABLE
• 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: 19760718
• Report Number: 0001822565-2024-02389
• Device Sequence Number: 20988797
• Product Code: HSB
• UDI-Device Identifier: 00889024062757
• UDI-Public: (01)00889024062757(10)64190382
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: 00249000300
• Device Lot Number: 64190382
• 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: 07/05/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2018
• 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
• Patient Sex: Unknown