MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL AMT NECK SEG 135D STD; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number	L94005
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
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 during a thr operation with the surgeon at (b)(6), during the trial phase of the operation, he stated the neck trial was not engaging on broach as it normally does, as it was getting stuck and needed extra force to seat the neck trial flush onto the broach.This issue did not cause any delays, however the surgeon has requested the instruments be replaced or serviced.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H6 (medical device problem code) device-device incompatibility (a1702) is used to capture jammed/seized and unable to assemble.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device associated with this report was received for examination.Visual examination of the returned devices did not confirm, a jamming condition.Both devices were separated from each other.Overall condition of the device is acceptable, no damages were observed.A functional test was performed with the returned mating devices.And the inability to assemble condition was not confirmed.Devices assembled, retained, and disassembled without restriction or difficulty as design intended.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.Device history lot: a manufacturing records evaluation (mre) was not performed, since a valid finished good lot number was not provided for this device.

• Brand Name: CORAIL AMT NECK SEG 135D STD
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex IN 69801 ; FR 69801
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14399181
• Report Number: 1818910-2022-08898
• Device Sequence Number: 5606128
• Product Code: LXH
• UDI-Device Identifier: 10603295325161
• UDI-Public: 10603295325161
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2022

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: L94005
• Device Catalogue Number: L94005
• Device Lot Number: NB101906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 06/23/2022; 07/29/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 06/27/2022; 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1818910-02/27/2019-001-C
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 124 KG