MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LARGE SHIELDED CALCAR PLANER; HIP INSTRUMENTS : REAMERS

Model Number L94010

Device Problems Failure to Cut (2587); Naturally Worn (2988)

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

Event Date 12/08/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

I have had it reported to me today that (b)(6) hospital used a corail set on (b)(6) 2021 and the neck trail of a corail would not fit onto the broken broach.They also have 2 blunt reamers through wear and tear.These are all from the same kit and i believe that they are all wear and tear.

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.H10 additional narrative: added: b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received indicated that the instruments did not break into two or more pieces and there was no surgical delay reported.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: no device was received for examination.Therefore, the reported event could not be confirmed.Depuy considers, the investigation closed.Should additional information be received, the information will be reviewed.And the investigation will 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.

• Brand Name: LARGE SHIELDED CALCAR PLANER
• Type of Device: HIP INSTRUMENTS : REAMERS
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 19380 ; 6107428552
• MDR Report Key: 13053113
• MDR Text Key: 284375727
• Report Number: 1818910-2021-28623
• Device Sequence Number: 1
• Product Code: LYS
• UDI-Device Identifier: 10603295325192
• UDI-Public: 10603295325192
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2021

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: L94010
• Device Catalogue Number: L94010
• Device Lot Number: ABE29765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 12/20/2021; 03/02/2022
• Supplement Dates FDA Received: 01/14/2022; 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2015
• 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