MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 CUP INTRODUCER 36MM; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	962600036
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2018
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
Trigger pivot screws have come out of introducer body.Rendering these instruments unusable."this case has been reported by the loan kit technician during loan kit inspection.It has been forwarded to depuy engineering for assessment.No further information can be obtained as the case was not reported by the customer".
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
Additional Manufacturer Narrative
(b)(4).Investigation summary depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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: CUP INTRODUCER 36MM
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 7897592
• Report Number: 1818910-2018-70030
• Device Sequence Number: 19238803
• Product Code: HWR
• UDI-Device Identifier: 10603295243267
• UDI-Public: 10603295243267
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2018

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: 962600036
• Device Lot Number: 0MS581024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 08/24/2018; 09/21/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 09/21/2018; 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1