MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ADAPTER REMOVER INSTRUMENT; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Model Number	2055-14-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Follow up has been conducted for information on reporter but no information has been made available at the date and time of this report.Investigation summary: as there was no reported failure, no confirmation of failure could occur but upon physical review of the instrument a determined extractor shaft is worn out.Depuy-synthes 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.
Event or Problem Description
Instrument was reported for unknown reason.Product was received and then investigated.

• Brand Name: ADAPTER REMOVER INSTRUMENT
• Common Device Name: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11181142
• Report Number: 1818910-2021-01303
• Device Sequence Number: 19543241
• Product Code: HWB
• UDI-Device Identifier: 10603295084495
• UDI-Public: 10603295084495
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2021

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
• Operator of Device: Health Professional
• Device Model Number: 2055-14-000
• Device Catalogue Number: 205514000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1