MAUDE Adverse Event Report: DEPUY IRELAND 9616671 HO NECK SEGMENT COR AMT; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number	L20433
Medical Device Problem Codes	Device-Device Incompatibility (2919); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/04/2020
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
It was reported that the surgeon was performing a hemi hip arthroplasty.After trialing the surgeon pulled the trials out of the patient but could not get trials to separate.They were using the corail system with the mod cathcart unipolar/bipolar tray.The neck trials from the corail system kept getting stuck on the spacer trials from the mod cathcart system.The case was delayed 10 minutes to retrieve alternate instruments.The patient was not harmed.Both instruments are being returned.
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.H6 component code is not applicable for this report.

• Brand Name: HO NECK SEGMENT COR AMT
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 10698131
• Report Number: 1818910-2020-22752
• Device Sequence Number: 14379880
• Product Code: LXH
• UDI-Device Identifier: 10603295258230
• UDI-Public: 10603295258230
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 10/04/2020

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: L20433
• Device Catalogue Number: L20433
• Device Lot Number: 5203909
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1