MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ALIGNMENT ROD; HIP INSTRUMENTS : ALIGNMENT DEVICES

Catalog Number	965368000
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device is an instrument and is not implanted/explanted.
Event or Problem Description
Discarded instruments from a c stem amt consignment kit discarded making the kit incomplete and not usable.Missing items: hohmann retractor 2181-10-000, pinnacle alignment rod 9653-68-000, box chisel small 2002-31-000, stem introducer 2522-00-502, 36mm -2 trial head 2531-5-0000.
Additional Manufacturer Narrative
This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.This does not meet a complaint definition, the electronic complaint record will be voided.Product complaint #: (b)(4).

• Brand Name: ALIGNMENT ROD
• Common Device Name: HIP INSTRUMENTS : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 8451516
• Report Number: 1818910-2019-88452
• Device Sequence Number: 14200369
• Product Code: HWT
• UDI-Device Identifier: 10603295246817
• UDI-Public: 10603295246817
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: UNK
• 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): 03/06/2019

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: 965368000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1