MAUDE Adverse Event Report: DEPUY MITEK LLC US MINI QA+ #2/0 ETH V-5 *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 212033

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); Not Applicable (3189); No Code Available (3191)

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Udi: (b)(4).

Event Description

It was reported by affiliate via complaint submission tool that during an unknown procedure the mini qa+ #2/0 eth v-5 *ea broke living the anchor in the bone.There was no patient consequence, however there was a 10 minutes surgical delay reported.The procedure was completed using sutures from a different bran.No additional information was provided.

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.H10 additional narrative: additional information: h6: method codes: device history lot: a manufacturing record evaluation was performed for the finished device lot number (l705585), and no non-conformances were identified.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (l705585), and no non-conformances were identified.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.

• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9613184
• MDR Text Key: 186141147
• Report Number: 1221934-2020-00256
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K992487
• 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: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 212033
• Device Lot Number: L705585
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 01/21/2020
• Supplement Dates Manufacturer Received: 02/25/2020
• Supplement Dates FDA Received: 02/26/2020
• Patient Sequence Number: 1