MAUDE Adverse Event Report: DEPUY MITEK LLC US VERSALOK PEEK WITH ORTHOCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 210818

Device Problems Entrapment of Device (1212); Material Separation (1562); Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Udi: (b)(4).The expiration date is unknown.

Event Description

It was reported by the sales rep via phone that upon removing the inserter of the versalok peek anchor with free strands of #2 orthocord from the bone, the inserter was bent and the sutures were freed, the physician was able to retrieve the internal part of the device but appears that the outer sleeve was missing in the patient´s body.Another device was used to complete the procedure.No delay reported.The device is available to be returned.

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: b5: subsequent follow-up with the customer, additional information was received.It was reported that it was no known how the device bent; however, it was reported that it was noticed when removing inserter.

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.H10 additional narrative: additional information received from the affiliate reported the surgeon was not able to retrieve the outer portion of the device.It is implanted in the bone.Corrected data: adverse event - b1 type of reportable event - h1 patient code - h6.Investigation summary: the sleeve peek and pin peek were not returned along with the inserter.The received inserter was inspected visually.Upon visual inspection, the distal tip of the inserter was found to be bent.The complaint can be confirmed for the reported bent condition.Since there is no xray/images provided, the complaint cannot be confirmed for that missing piece left in the patient body.The bent condition indicated blunt force impact; potential root causes could be the device hit bone during a procedure.A manufacturing record evaluation was reviewed, no non-conformances were identified for the reported part 210818- lot l790088 number combination.At this 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

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: correction: h6: the device codes were updated to reflect the missed information on the initial report.Additional information: d4 h10: the expiration date was reported as unknown on the initial report and has been updated accordingly.Therefore, udi: (b)(4).

• Brand Name: VERSALOK PEEK WITH ORTHOCORD
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9842871
• MDR Text Key: 204358199
• Report Number: 1221934-2020-00877
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001323
• UDI-Public: 10886705001323
• Combination Product (y/n): N
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/03/2020

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: 03/31/2021
• Device Model Number: 210818
• Device Catalogue Number: 210818
• Device Lot Number: L790088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 03/20/2020; 04/28/2020; 04/30/2020
• Supplement Dates FDA Received: 03/30/2020; 04/29/2020; 04/30/2020
• Patient Sequence Number: 1