MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN BANTAM CUP IMPACTOR ADAPT

Catalog Number	221750048
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2017
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 during surgery while surgeon impacting the cup using the adaptor (part#: 221750048, lot#: unknown) connected to an impactor (part#: unknown), the adaptor got disconnected and then left on the cup.He removed the adaptor from the cup using a long nose pliers and so on.Doe: (b)(6) 2017; surgical delay: 10 minutes.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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: PIN BANTAM CUP IMPACTOR ADAPT
• Common Device Name: IMPACTOR
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7117497
• Report Number: 1818910-2017-51691
• Device Sequence Number: 13820400
• Product Code: HWA
• UDI-Device Identifier: 10603295099000
• UDI-Public: 10603295099000
• Combination Product (Y/N): N
• 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): 11/21/2017

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1