MAUDE Adverse Event Report: DEPUY MITEK LLC US RGDFIX FEM3.3MM ST BR XPIN KIT; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	210816
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).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.No nonconformances were identified for this part number (210816), lot number (l883103).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.
Event or Problem Description
It was reported by the sales rep via phone that during an acl reconstruction procedure the sales rep's rigidfix 3.3mm femoral cross pin kit sheath broke while attempting to remove from the patient.The sales rep stated that while inserting the implant, the wire arms snapped off while it was being drilled in and the proximal end of the sheath separated from the distal end.The sales rep stated that the patient had hard bone.The sales rep stated that the remainder of the sheath was left in the patient and that is how the case was completed.They took an x-ray and chose to leave it in.The sales rep stated there is no plan for surgical intervention.There was a fifteen minute delay to remove the proximal end of the sheath and end the surgery.The device is not returning as it is implanted in the patient.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: RGDFIX FEM3.3MM ST BR XPIN KIT
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8043730
• Report Number: 1221934-2018-55214
• Device Sequence Number: 19177418
• Product Code: MAI
• UDI-Device Identifier: 10886705001309
• UDI-Public: 10886705001309
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 210816
• Device Lot Number: L883103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1