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

Model Number	L94003
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
Trial head did not fit onto trial neck due to damage of the metal o ring, trials all need replacing off consigned kit, hana table femoral bolster and perineal post padding needs replacing due to ripping of rubber.
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.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
Event or Problem Description
Additional information received as per engineer¿s assessment the reference the other four neck segments which are still in good order and are functioning as they should that these four neck segments l94003, l94005, l94006 and l94007 be returned to the field.

• Brand Name: CORAIL AMT NECK SEG 125D STD
• 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: 9741106
• Report Number: 1818910-2020-05684
• Device Sequence Number: 2401745
• Product Code: LXH
• UDI-Device Identifier: 10603295325147
• UDI-Public: 10603295325147
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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 Model Number: L94003
• Device Catalogue Number: L94003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1