MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DRIVER EXTRACTOR; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Model Number	2046-10-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
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
It was reported that the 32 mm impactor tip worn, old, cracking.Found when set returned to the office for inspection.36 mm impactor tip worn, old, cracking.Found when set returned to the office for inspection.T-handle cracked.Found when set returned to the office for inspection.Driver extractor separated.Found when set returned to the office for inspection.No surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the instrument associated with this report was not returned.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.

• Brand Name: DRIVER EXTRACTOR
• Common Device Name: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11286407
• Report Number: 1818910-2021-02485
• Device Sequence Number: 3842891
• Product Code: HWB
• UDI-Device Identifier: 10603295084365
• UDI-Public: 10603295084365
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 2046-10-000
• Device Catalogue Number: 204610000
• Device Lot Number: SO2021443
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1