MAUDE Adverse Event Report: DEPUY MITEK LLC US RGDFX CRVE ST ACL PLA XPIN SYS; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 213013

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The expiration date is not currently available.

Event Description

It was reported that after the insertion of the pin.The surgeon noted a little piece of the pin to be detached.The broken pin was removed and the intervention was concluded inserting a new pin.No adverse event for the patient.

Manufacturer Narrative

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.Pma/510k: awareness data for follow up report 2 initially reported as may 07, 2018 but should have been january 22, 2019.Awareness date for follow up report 3 was reported as january 22, 2019 but should have been february 25, 2019.Device was used for treatment, not diagnosis.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).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 medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device is not available for a physical evaluation.This complaint is not confirmed.Without physically evaluating the device, a definite root cause cannot be determined.Furthermore, no lot number was supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).The expiration date is currently unavailable.

Event Description

Additional information received on 10/15/2018.It was reported that no defective device will be returned.Sales rep confirmed it was lost.

Manufacturer Narrative

Product complaint # (b)(4).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.Investigation summary: the device is not available for a physical evaluation.This complaint is not confirmed.Without physically evaluating the device, a definite root cause cannot be determined.Non conformance review was performed, no nonconformances were identified for this part(213013)-lot (l668683) number combination.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.Corrected data: (g4) date received by manufacturer changed from 5/7/2018 to 01/22/2019.

• Brand Name: RGDFX CRVE ST ACL PLA XPIN SYS
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7570305
• MDR Text Key: 110177251
• Report Number: 1221934-2018-51338
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 20886705020000
• UDI-Public: 20886705020000
• Combination Product (y/n): N
• PMA/PMN Number: K130105
• 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,Followup
• Report Date: 05/07/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 213013
• Device Lot Number: L668683
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 10/15/2018; 05/07/2018; 01/22/2019; 05/16/2019
• Supplement Dates FDA Received: 10/25/2018; 01/28/2019; 02/25/2019; 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1