MAUDE Adverse Event Report: DEPUY MITEK LLC US GII QA+ O/C CP-2 *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 222983

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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

Suture broke while the surgeon was tying the knot.No patient consequence is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

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.Investigation summary: the complaint device was received and evaluated.The anchor tip and suture were missing.The incident report does not indicate where and how the suture broke and it is unclear if there were any immediate causes for this failure.No visual evidence was provided as the suture was not returned for evaluation.The complaint cannot be confirmed.A dhr 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 evidence of manufacturing anomalies on the paperwork reviewed.A review into the mitek complaints system revealed no other complaint of any kind for this lot of devices.At this point in time, no corrective action is required and no further action is warranted.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).

Event Description

Suture broke while the surgeon was tying the knot.No patient consequence.Is the information being submitted for this complaint all the details that are known/available regarding this event?: yes.

• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7451469
• MDR Text Key: 106854165
• Report Number: 1221934-2018-50505
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 10886705008612
• UDI-Public: 10886705008612
• Combination Product (y/n): N
• PMA/PMN Number: K051989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 222983
• Device Lot Number: L613017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Date Manufacturer Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1