MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 BROACH CORAIL AMT 12; HIP INSTRUMENTS : BROACHES

Catalog Number L20412

Device Problem Fitting Problem (2183)

Patient Problem Not Applicable (3189)

Event Date 02/18/2019

Event Type  malfunction  

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 Description

Consignment instrument (corail stem inserter) was damaged by surgeon while trying to remove a half-inserted corail stem.Stem becmae 'stuck' 3-5mm higher than anticipated, surgeon removed the threaded shaft from the inserter, attached it to the stem, and began impacting the underside of the impaction plate to try to remove the stem.

Manufacturer Narrative

(b)(4).Investigation summary
=
> no device was received.Root cause undetermined.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: BROACH CORAIL AMT 12
• Type of Device: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; b.p. 256; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8499299
• MDR Text Key: 141456706
• Report Number: 1818910-2019-90286
• Device Sequence Number: 1
• Product Code: HTQ
• UDI-Device Identifier: 10603295258148
• UDI-Public: 10603295258148
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: L20412
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1