MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 STD NECK SEGMENT CORAIL AMT; HIP INSTRUMENTS : BROACHES

Model Number	L20431
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/15/2021
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
It was reported that on (b)(6) 2021, the patient underwent the surgery via bhp with the broach and neck trial in question.During the surgery, the surgeon tried to attach a neck trial into the broach, but it did not go smoothly.The surgeon struck the neck trial with a hammer, and he managed to attach it, but couldn't remove the trail neck.And then, the surgeon opened the gap between the broach and neck trial with chisel, and he struck the neck trial retrogradely by using elevators which hospital owns and he managed to remove it.The surgeon commented that products such as corail and actis require using a calcar reamer, but it is not so sharp.The surgeon guesses that when calcar reaming is performed with too much power, the broach neck was damaged, and it couldn't be attached the trail neck.The surgery was completed successfully within 30 minutes delay.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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 manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: STD NECK SEGMENT CORAIL AMT
• Common Device Name: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12908086
• Report Number: 1818910-2021-26613
• Device Sequence Number: 19838121
• Product Code: LXH
• UDI-Device Identifier: 10603295258216
• UDI-Public: 10603295258216
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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: L20431
• Device Catalogue Number: L20431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown