MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EXCEL CALCAR MILL LARGE; HIP INSTRUMENTS : CUTTING INSTRUMENTS

Model Number 2001-49-000

Device Problems Failure to Cut (2587); Material Deformation (2976); Illegible Information (4050)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # : (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that all calcar planar sets are too dull to assist in surgery.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this complaint was retuned for examination.Visual analysis of the device found blunting of cutting edges.It is not unreasonable that the condition identified in visual analysis would contribute to a dull condition.Therefore we are able to confirm dullness with damage observed, as this kind of evidence indicates constant and heavy usage of the device.However, no evidence of deformation or illegible etch was found.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation mre was not performed.

Event Description

Additional information received indicates that the lot number was smugged and numbers weren't clear.It was bent during surgery, not broken.

Manufacturer Narrative

Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: EXCEL CALCAR MILL LARGE
• Type of Device: HIP INSTRUMENTS : CUTTING INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16435581
• MDR Text Key: 310249803
• Report Number: 1818910-2023-04437
• Device Sequence Number: 1
• Product Code: LYS
• UDI-Device Identifier: 10603295080022
• UDI-Public: 10603295080022
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2023

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
• Device Operator: Health Professional
• Device Model Number: 2001-49-000
• Device Catalogue Number: 200149000
• Device Lot Number: HW91875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 02/28/2023; 03/15/2023
• Supplement Dates FDA Received: 03/01/2023; 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1