MAUDE Adverse Event Report: DEPUY IRELAND 9616671 CORAIL AMT SZ10 125 STD COL; ALIGNMENT DEVICE

Catalog Number L971210

Device Problems Device-Device Incompatibility (2919); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  malfunction  

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 Description

Incident occurred during the procedure : the impactor got stuck in the neck of the rod.On march 1, there was a problem when removing the impactor, which remained attached to the stem.This reduced the strength of the final stem and caused it to sink in.Then it was necessary to explant it during a second surgery.

Manufacturer Narrative

Product complaint # : pc-(b)(4).This device was also subject of pc-(b)(4) as a reported adverse event associated with devices lead to a subsequent adverse event associated with patient.H6 medical device problem code: appropriate term / code not available (e2402) utilized to capture device-device incompatibility (a1702).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : examination of the returned stem finds nothing outward to suggest product error.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.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 search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: CORAIL AMT SZ10 125 STD COL
• Type of Device: ALIGNMENT DEVICE
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co; cork IN ; EI
• MDR Report Key: 11574274
• MDR Text Key: 242408917
• Report Number: 1818910-2021-06199
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: L971210
• Device Lot Number: 9606417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1