MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CUP IMPACTOR TIP 22.225; HIP INSTRUMENTS : INSERTION DEVICES

Model Number	2217-50-004
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2020
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
Mdr staff have noticed the pinnacle cup impactor tip (221750004) is cross threaded and no longer usable for surgery.Item was discarded.No further information is available.Please send replacement direct to the following address:.
Additional Manufacturer Narrative
Product complaint # = > pc(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: PINN CUP IMPACTOR TIP 22.225
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10088289
• Report Number: 1818910-2020-12564
• Device Sequence Number: 2850795
• Product Code: LXH
• UDI-Device Identifier: 10603295098935
• UDI-Public: 10603295098935
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2020

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: 2217-50-004
• Device Catalogue Number: 221750004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1