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

Model Number 222984

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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 mail the super qa+ o/c ds cp-2 *ea.During shoulder repair procedure, after tapping the anchor into the patient's bone, the white plastic part and the metal rod came apart separately not together as per usual.Following this the sutures came loose instantly.¿ surgeon is very familiar with superquick anchor.Implanted 2 in the patient before with no issue.The device is not available to be returned for evaluation (implanted).Additional information received from the affiliate reported the event occurred intra-operative and additional surgical intervention was not required.It was reported there were no patient consequences.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary
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> according to the information provided, it was reported that during shoulder repair procedure, after tapping the anchor into the patient's bone, the white plastic part and the metal rod came apart separately not together as per usual.Following this the sutures came loose instantly.The anchor is still implanted in the patient, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, it was observed that the anchor was not in place due to it was implanted.The shaft and the suture showed blood residues.The suture was frayed but it was not possible to see in which specific part was broken.Also, it was not assembled in the device and the suture card is not in place.The photo provide evidence of the defect in the device, therefore the complaint reported can be confirmed.As a result, we cannot discern a root cause for the reported failure, but the possible could be related the high tension on the suture and when applying excessive force while inserting the anchor beyond its intended use causing damage in the suture, also, it can causing to snap; however, it cannot be conclusively affirmed.Hands on analysis should provide more evidence to be able to discern a root cause.A manufacturing record evaluation was performed for the finished device [5l95450] number, 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.Udi: (b)(4).

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary
=
> according to the information provided, it was reported that during shoulder repair procedure, after tapping the anchor into the patient's bone, the white plastic part and the metal rod came apart separately not together as per usual.Following this the sutures came loose instantly.The complaint device is still implanted in the patient, therefore unavailable for a physical evaluation.Since the complaint device remains implanted, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device [5l95450] number, 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: 10072559
• MDR Text Key: 207751106
• Report Number: 1221934-2020-01409
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705008629
• UDI-Public: 10886705008629
• Combination Product (y/n): N
• PMA/PMN Number: K052631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2020

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: No Information
• Device Expiration Date: 08/31/2022
• Device Model Number: 222984
• Device Catalogue Number: 222984
• Device Lot Number: 5L95450
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 08/04/2020; 08/04/2020
• Supplement Dates FDA Received: 08/04/2020; 08/04/2020
• Patient Sequence Number: 1