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

Catalog Number	210818
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional 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).
Event or Problem Description
It was reported by the sales rep via phone that during a rotator cuff repair procedure the customer's versalok peek anchor with orthocord distal portion of the anchor peeled up as it was being malleted and would not advance correctly into the patient.The sales rep stated that the anchor was removed with no debris left behind.The patient had hard bone.The case was completed with another like-anchor in the same bone hole with no patient harm or surgical delay.The anchor is being returned for evaluation.
Additional 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 initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received and evaluated.Visual observation revealed that the distal portion of the versalok peek anchor was peeled.Hence, preventing the device from advancing correctly into the bone.Therefore, this complaint can be confirmed.We cannot determine a definitive root cause for the reported failure.However, given the information provided, it is possible that the device could have been used off-axis during the procedure.Hence, causing the anchor to peel when contacting the hard bone.Furthermore, a non-conformance search was performed and no non-conformances were identified for this part number (210818) lot number (2l32153) 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.Udi: (b)(4).

• Brand Name: VERSALOK PEEK WITH ORTHOCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8604600
• Report Number: 1221934-2019-57126
• Device Sequence Number: 14186686
• Product Code: MAI
• UDI-Device Identifier: 10886705001323
• UDI-Public: 10886705001323
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 210818
• Device Lot Number: 2L32153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 06/21/2019
• Patient Sequence Number: 1