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

Model Number 212134

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

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).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 6 of 6 for the same event.It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure, it was observed that six anchors on suture the gii qa+ #2 pan cp-2 *ea device broke.There was a delay of 10 - 15 minutes in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

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.Additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that there were factors that caused the device breakage.It was reported that an alternative product was readily available.It was reported that another thread was available.It was reported that the case was completed by using another thread.It was reported that there was no surgical intervention planned (e.G.X-rays, additional/change in procedures, prescriptions, otc, revisions).It was reported that the surgical procedure involved was unknown.

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Corrected data: additional information received by the affiliate reported the customer mistakenly stated factors caused the anchor to break.The affiliate reported the customer stated this was reported in error and external factors did not cause the device breakage.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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: investigation summary
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> the reported sutures were received without any anchor and shaft.It was noticed that all the suture was found to be frayed/ broken.Hence, the complaint can be confirmed.Based on given information we cannot discern a definitive root cause for the reported failure.However, it is possible that the suture broke due to the high tension.No structural anomalies were observed.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
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> a manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), and no non-conformances were identified.

• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9505864
• MDR Text Key: 207613543
• Report Number: 1221934-2019-60098
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 10886705001989
• UDI-Public: 10886705001989
• Combination Product (y/n): N
• PMA/PMN Number: K915889
• 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,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 212134
• Device Catalogue Number: 212134
• Device Lot Number: 5L29726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1