MAUDE Adverse Event Report: DEPUY MITEK GII QA+ W #2 ORTHOCORD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 222983

Device Problem Break (1069)

Patient Problems Local Reaction (2035); No Consequences Or Impact To Patient (2199)

Event Date 10/30/2017

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The expiration date is not currently available.

Event Description

The sales rep reported via phone that the suture on the customer's gii anchor with orthocord snapped when tying it down during a bicep repair.The anchor was left in the patient and an arthrex button was used to complete the case.There were no patient consequences or delays.The suture was discarded by the customer.

Manufacturer Narrative

Product complaint # (b)(4).Expiration date has been updated.Therefore, udi has been updated.Date of manufacture has been updated.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.This complaint cannot be confirmed.No nonconformances were identified for this part-lot number combination.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of devices that were released to distribution.At this point, 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).

• Brand Name: GII QA+ W #2 ORTHOCORD
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS SARL TOLLER MITEK; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 7069109
• MDR Text Key: 93281635
• Report Number: 1221934-2017-50010
• Device Sequence Number: 1
• Product Code: JDR
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 222983
• Device Lot Number: L393385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2017
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other