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

Catalog Number	210818
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).(b)(4).
Event or Problem Description
It was reported by the affiliate via email that the versalok peek anchor with free strands of orthocord was defective and could not be used.Detailed description will follow.Additional information provided by the affiliate reported when using an anchor from (b)(6) 2018 the threading of the threads and the subsequent wrapping was easily possible.However, after tightening with the special instrumentation, the anchor could not be locked over the handle as usual.It was also reported that the handle could be pressed but the threads were not fixed in the strained position.Since no holding function was possible, the anchor had to be removed again and replaced by another anchor.
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.H10 additional narrative: 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 is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.No nonconformances were identified for this part-lot number combination per qlik query executed on 06/27/2019.One possible root cause is the versalok gun was not locked onto the inserter rod properly prior to tensioning the sutures, however without the return of the complaint device, we cannot determine a definitive root cause with the information provided.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).

• 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: 8731779
• Report Number: 1221934-2019-57424
• Device Sequence Number: 1729844
• Product Code: MAI
• UDI-Device Identifier: 10886705001323
• UDI-Public: 10886705001323
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2019

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: 05/31/2021
• Device Catalogue Number: 210818
• Device Lot Number: L882974
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 07/25/2019
• Patient Sequence Number: 1