MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE 62MM GRIPPER; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	221890062
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	05/24/2018
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
For this surgery, ceramic insert (liner) was requested, and when we used the instruments to insert the ceramic liner, we had great difficulty in releasing the implant from the instruments.We used the correct technique but the implant did not easily get loose from the instruments.This situation generated surgeon dissatisfaction.The instrumental also scratched the ceramic implant a bit.Find attached photos of the instruments with the codes of each piece used.It generated a delay in surgery of approximately 15 minutes.It caused no injury to the patient.(b)(6).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned instrument cannot confirm 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, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE 62MM GRIPPER
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7614212
• Report Number: 1818910-2018-62602
• Device Sequence Number: 1555626
• Product Code: LXH
• UDI-Device Identifier: 10603295102335
• UDI-Public: 10603295102335
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 05/24/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 221890062
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention