MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT SZ13 135 HIGH COL; CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM

Model Number	L971113
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Insufficient Information (4580)
Date of Event	02/05/2020
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
Event: punctured inner packaging.Upon removal of the inner packaging from the outer box it was noted by the circulating nurse that there was a hole in the top covering of the package containing the sterile implant.No evident damage to the outer box could be seen to explain this event.The clear plastic film on the outer box was also undamaged.As the hole was in the package protecting the sterile implant it was deemed appropriate not to use this implant and another one was opened and used in its place.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned packaged device, and provided photographs confirms the reported observation.The investigation did not identify and error in processing.The direct root cause was not identified.It was however determined that the damage occurred post distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : a full dhr review at every step of the process was conducted.No related deviations or anomalies were identified.Device history review : a full dhr review at every step of the process was conducted.No related deviations or anomalies were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned packaged device, and provided photographs confirms the reported observation.The investigation did not identify and error in processing.The direct root cause was not identified.It was however determined that the damage occurred post distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : a full dhr review at every step of the process was conducted.No related deviations or anomalies were identified.Device history review: a full dhr review at every step of the process was conducted.No related deviations or anomalies were identified.

• Brand Name: CORAIL AMT SZ13 135 HIGH COL
• Common Device Name: CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 9757222
• Report Number: 1818910-2020-06058
• Device Sequence Number: 1865873
• Product Code: KWA
• UDI-Device Identifier: 10603295455325
• UDI-Public: 10603295455325
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2020

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 Expiration Date: 01/31/2024
• Device Model Number: L971113
• Device Catalogue Number: L971113
• Device Lot Number: 9030890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 01/08/2021; 06/10/2021
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 01/08/2021; 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR