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

Catalog Number 212035

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2017

Event Type  malfunction  

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).The expiration date is not currently available.Associated medwatches: 1221934-2018-50072 and 1221934-2018-50073.

Event Description

It was reported by the customer that three of there mini quick anchor #2/0 orthocord v-5 were deploying too hard during an unknown procedure.The case was completed with another like device.There were no patient consequences or delays.The devices are being returned.

Event Description

It was reported by the customer that three of there mini quick anchor # 2/0 orthocord v-5 were deploying too hard during an unknown procedure.The case was completed with another like device.There were no patient consequences or delays.The devices are being returned.

Manufacturer Narrative

Product complaint # (b)(4).Three brand new unused devices were received from the sales representative.He was contacted to returned the complaint devices for evaluation.Udi: (b)(4).The expiration date is not currently available.Associated medwatches: 1221934-2018-50072 and 1221934-2018-50073.

Event Description

Additional information received on 11/1/2018.The sales rep communicated that the 3 brand new devices were the remainder of the lot, which were requested by the customer to be sent back.However, the complaint devices were discarded.

Manufacturer Narrative

Product complaint # (b)(4).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.If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

Manufacturer Narrative

Product complaint #: (b)(4).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.Investigation summary: the complaint device is not available for physical evaluation, hence, the complaint cannot be confirmed.A member of new product development (npd) was consulted for further insight into the failure mode.The npd engineer indicated that some potential causes for the anchor being difficult to deploy could be harder than usual patient bone, or the surgeon not drilling a big enough hole for the anchor thus causing a tighter fit than normal, or the surgeon thought they used the correct drill size but it was smaller.However, given the information provided we cannot discern a definitive root cause for the reported failure.A non-conformance search was conducted to investigate any defects during production identified that may contribute to the complaint condition.No non-conformance was identified for this part-lot number combination.At this point, 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.Device history lot: no non-conformance was identified for this part/lot number combination per qlik query executed 11/01/2018.Review conducted per (b)(4).D10: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

• Brand Name: MINI QA+ #2/O OCORD V-5
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7199582
• MDR Text Key: 97663877
• Report Number: 1221934-2018-50074
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K071257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/18/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2018
• Device Catalogue Number: 212035
• Device Lot Number: L302230
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 01/17/2018
• Supplement Dates Manufacturer Received: 03/12/2018; 11/01/2018; 12/04/2018
• Supplement Dates FDA Received: 03/12/2018; 11/05/2018; 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1