MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 COR VAR NECK SEGMENT COR AMT; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number	L20432
Medical Device Problem Codes	Break (1069); Crack (1135); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2020
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
Corail kla neck trial bearing is broken, it is getting stuck on the corail broach trial, and having a difficult time getting it off of the trial.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.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.Corrected: (medical device problem code) medical device problem code: removed the code for break and replaced with crack ((b)(4)).
Event or Problem Description
Additional information received indicated that the rubber ring in the neck trial was cracked.

• Brand Name: COR VAR NECK SEGMENT COR AMT
• 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: 10730561
• Report Number: 1818910-2020-23258
• Device Sequence Number: 19361331
• Product Code: LXH
• UDI-Device Identifier: 10603295258223
• UDI-Public: 10603295258223
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

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: L20432
• Device Catalogue Number: L20432
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1