MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PINNACLE AB TAMP EXTRACTOR; PROJECT NEPTUNE : EXTRACTION INSTRUMENTS

Catalog Number	221760120
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	05/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
I don't have the details yet on some of the products involved, pinn cup and ceramic insert and head.It was a revision and they had major problems removing ceramic insert.They tried the alternative bearings removing instrument, the small ceramic extractor and nothing worked.They spend at least an hour trying to remove the insert.They even called me from the or to verify if they were using the right instruments and technique, but nothing worked.They finally tried to cut the ceramic insert with a midasrex diamond burr with no results.They finally opted to try to remove the cup with the insert still in it using zimmer's explant instrument.While tapping on the handle, the ceramic insert finally cracked and they were able to remove it.A t handle was also broken during this case, part of the tip broke, due to wear.Also a ceramic extractor tip was damaged.
Additional 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE AB TAMP EXTRACTOR
• Common Device Name: PROJECT NEPTUNE : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7583073
• Report Number: 1818910-2018-61656
• Device Sequence Number: 11391758
• Product Code: MRA
• UDI-Device Identifier: 10603295424161
• UDI-Public: 10603295424161
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 221760120
• Device Lot Number: NW146105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Initial Date Received by Manufacturer: 05/11/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1