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

Catalog Number 200148000

Device Problems Device-Device Incompatibility (2919); Naturally Worn (2988)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  malfunction  

Event Description

It was reported that while implanting a pinnacle acetabular shell, a mallet strike caused a small sliver of metal to break off of the strike plate of the pinnacle insertion handle and stick into the surgeon's glove.The insertion handle was removed from the field and a new one was used to finish impacting the shell.1 minute of surgical time was added.In addition to this, an actis medium calcar planer became cross threaded and will no longer attach to a planer shaft.The small calcar planer was used in its place.No surgical time was added.

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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.

Event Description

Additional information was received stating that there were no adverse consequences to the patient and no pieces broke off of the calcar mill.The surgeon did change his gloves but his hands were not injured.

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.H6 (clinical and impact codes).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 records evaluation (mre) was not performed.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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: CALCAR MILL MEDIUM
• 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 ; 3035526892
• MDR Report Key: 18717795
• MDR Text Key: 336244866
• Report Number: 1818910-2024-03456
• Device Sequence Number: 1
• Product Code: LYS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 02/15/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 200148000
• Device Lot Number: HW89850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 02/21/2024; 02/21/2024
• Supplement Dates FDA Received: 02/21/2024; 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2019
• 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