MAUDE Adverse Event Report: DEPUY MITEK LLC US RGDFIX 2.7MM BTB BR XPIN KIT; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	210815
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Incomplete.The expiration date is currently unavailable.
Event or Problem Description
It is reported by our sales rep that during the procedure, rigidfix sheath snapped upon insertion.New kit was opened and used.There is no patient consequence.
Additional 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.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.Evaluation statement: the complaint device is not being returned, multiples attempts for product return were made with no response, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A device history record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.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).H11: corrected data: b4 date of this report.

• Brand Name: RGDFIX 2.7MM BTB 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: 7351294
• Report Number: 1221934-2018-50317
• Device Sequence Number: 39494
• Product Code: MAI
• UDI-Device Identifier: 10886705001293
• UDI-Public: 10886705001293
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2018

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: 12/31/2019
• Device Catalogue Number: 210815
• Device Lot Number: L266153
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR