MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT NECK SEG 125D KLA; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number	L94004
Medical Device Problem Code	Metal Shedding Debris (1804)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.
Event or Problem Description
We examined our loan sets (6) and found many had this debris.(b)(4).Six sets.We examined our loan sets (6) and found many had this debris, these have all been cleaned and remain in circulation.They are now inspected when they return to our facility, and none have been found to have further debris build up.
Additional Manufacturer Narrative
(b)(4).The affected devices were not returned for analysis.The information provided was evaluated.A field safety action was initiated to address this issue.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.The issue will be monitored through post market surveillance reviews.
Additional Manufacturer Narrative
(b)(4).The affected devices were not returned for analysis.The information provided was evaluated.A field safety action was initiated to address this issue.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.The issue will be monitored through post market surveillance reviews.

• Brand Name: CORAIL AMT NECK SEG 125D KLA
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7490297
• Report Number: 1818910-2018-58989
• Device Sequence Number: 19186638
• Product Code: LXH
• UDI-Device Identifier: 10603295325154
• UDI-Public: 10603295325154
• Combination Product (Y/N): N
• PMA/510(K) Number: K142004
• 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): 04/11/2018

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: L94004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1