MAUDE Adverse Event Report: DEPUY MITEK LLC US GII EASY ARTHRO #2 ETH *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	212450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, it was discarded and therefore is unavailable for a physical evaluation.A batch 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 and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in 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).
Event or Problem Description
The sales rep reported during a shoulder procedure, after the customer's gii anchor was inserted, the suture broke while being tensioned.The surgeon removed the anchor and used another like device to complete the procedure.There were no patient consequences.The procedure was extended about 10 minutes.The facility discarded the device.The sales rep was not present at the case.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).This follow up medwatch will be submitted to include the following statement that was missed from the initial report: this report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7730263
• Report Number: 1221934-2018-52870
• Device Sequence Number: 16779696
• Product Code: JDR
• UDI-Device Identifier: 10886705002061
• UDI-Public: 10886705002061
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K915889
• 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,Followup
• Report Date (Section B): 11/10/2014

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: 12/31/2018
• Device Catalogue Number: 212450
• Device Lot Number: 3748804
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2014
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 07/29/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1