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

Catalog Number	213013
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device was used for treatment, not diagnosis.Investigation summary: the complaint device is not being returned, therefore is unavailable for a physical evaluation.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.Furthermore, no lot number was supplied which precludes conducting a lot history review specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.This complaint cannot be confirmed.This complaint file is being closed, should any new information be received in the future, this file will be reopened at that time and updated to reflect the information received.At this time, no corrective action is required, and no further action is warranted.However, depuy 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.(b)(4)-incomplete.The lot number is not currently available.
Event or Problem Description
It was reported that after x-ray inspection the doctor sees that there is a small piece of metal in the bone.The piece of metal is from the sleeve that was necessary for insertion of the anchor.Lot number isn't available.The metal sleeve closes flush with the bone.The doctor sees no risk for the patient.No harm to the patient.No further information available.

• Brand Name: RGDFX CRVE ST ACL PLA XPIN SYS
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7786538
• Report Number: 1221934-2018-54502
• Device Sequence Number: 2012987
• Product Code: HTY
• UDI-Device Identifier: 20886705020000
• UDI-Public: 20886705020000
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 213013
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 08/15/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other