MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US OSTEOTOME 6MM X 6 IN; HIP INSTRUMENTS : CUTTING INSTRUMENTS

Model Number	2422-45-000
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The instruments are damaged.These osteotome blades are used only for revision surgery, since receiving the items and covid restrictions, use of these instruments have been at least twice since purchase.After decontamination of the instruments, a noticeable change in the blades have been reported by the hospital.The blades are bent and appear unusable.This kit has since been quarantined and a request from the hospital for us to please review and replace as these items are fairly new.
Additional 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.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: examination of the returned device confirmed, the reported bent condition.The noted, deformation is consistent with suspected unintended misuse/misapplication through off axis loading, during use.And the investigation did not establish a need for corrective action.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.

• Brand Name: OSTEOTOME 6MM X 6 IN
• Common Device Name: HIP INSTRUMENTS : CUTTING INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10970028
• Report Number: 1818910-2020-26529
• Device Sequence Number: 11343505
• Product Code: HWM
• UDI-Device Identifier: 10603295123279
• UDI-Public: 10603295123279
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2020

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 Model Number: 2422-45-000
• Device Catalogue Number: 242245000
• Device Lot Number: VZ15766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 12/29/2020; 01/29/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/11/2021; 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1