MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PIN BANTAM CUP IMPACTOR ADAPT; HIP INSTRUMENTS : IMPACTORS

Catalog Number	221750048
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
Event: total hip replacement surgery was performed, at the time of placing the final acetabular cup pinnacle # 40, and unscrewing the entire positioner of the cup after being impacted on its acceptability.The piece in question is "stuck in the cup", this incident causes the surgeon to have to use other clamps to unscrew the piece from the cup, risking that the same cup moved from where it should go.Finally, the piece is unscrewed in a somewhat abrupt manner.The procedure is finished without any other inconvenience.
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Product complaint # : (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.Device history lot : null.Device history batch : null.Device history review : null.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: PIN BANTAM CUP IMPACTOR ADAPT
• Common Device Name: HIP INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8256955
• Report Number: 1818910-2019-81279
• Device Sequence Number: 2306986
• Product Code: HWA
• UDI-Device Identifier: 10603295099000
• UDI-Public: 10603295099000
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2018

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 Catalogue Number: 221750048
• Device Lot Number: PG256200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2018
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 02/12/2019
• Patient Sequence Number: 1
• Patient Age: 82 YR