MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CONE REAMER EXTENSION; HIP INSTRUMENTS : ADAPTORS

Model Number 2576-00-008

Device Problem Device-Device Incompatibility (2919)

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

Event Date 04/29/2021

Event Type  malfunction  

Manufacturer Narrative

(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

It was reported as "instruments were used in surgery.Upon inspection of those instruments this morning, (b)(6) , we noticed some defects in the two sleeve trials making it difficult to use with the "sleeve introducer" handle.We also inspected the reamer handle and it was difficult to lock on the conical reamers.These issues were not mentioned in surgery, however, after speaking with the surgical tech today, (b)(6) , he asked me to take a look." no surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy considers the investigation closed at this time.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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.Corrected: h3.

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.

Event Description

Additional information received indicated that the handle sheath was difficult to fully pull down, perhaps, needed to be lubricated.The sleeves had appeared to be cut by a blade or osteotome around the top making it difficult for the introducer to work.

• Brand Name: CONE REAMER EXTENSION
• Type of Device: HIP INSTRUMENTS : ADAPTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11794033
• MDR Text Key: 249674666
• Report Number: 1818910-2021-09839
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295145301
• UDI-Public: 10603295145301
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2576-00-008
• Device Catalogue Number: 257600008
• Device Lot Number: SO2013062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR