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

Catalog Number	221750048
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2018
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
Rubber bung on pinnacle bantam cup impactor came loose and fell into pelvic crevice intraoperatively.No patient compromise as surgeon was able to fish rubber bung out.Patient consequence? :no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.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.Original coding is incorrect for breakage.The complaint description states the ring came loose and fell into pelvic crevice intraoperatively.No patient compromise as surgeon was able to fish rubber bung out.No mention of breakage.
Event or Problem Description
Update: original coding is incorrect for breakage.The complaint description states the ring came loose and fell into pelvic crevice intraoperatively.No patient compromise as surgeon was able to fish rubber bung out.No mention of breakage.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.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: 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: 7753475
• Report Number: 1818910-2018-65841
• Device Sequence Number: 1678895
• Product Code: HWA
• UDI-Device Identifier: 10603295099000
• UDI-Public: 10603295099000
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/11/2019

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: 07/09/2018
• Supplement Date Received by Manufacturer: 10/04/2018; 07/11/2019; 08/23/2019
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 10/04/2018; 07/12/2019; 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1