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

Catalog Number	210818
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Injury (2348); Foreign Body In Patient (2687)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
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.Udi: (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 free strands of #2 orthocord broke upon insertion while unscrewing the inserter.The eyelet portion of the implant was removed from the patient, but the distal portion of the implant remained inside the patient.The sales rep stated that the patient did not have any abnormal bone density and there were no abnormal procedural factors.The sales rep stated they are not planning any surgical intervention.The case was completed with another like-device with a new bone hole and there was no delay to the case.The eyelet portion of the device is being returned for evaluation.
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.Evaluation statement: the complaint device was received and evaluated.As reported the versalok inserter and a portion of the anchor was returned.As reported the remaining portion of the anchor was left in the patient.This complaint is confirmed.The versalok inserter shaft pusher has visible signs of surgical debris, and the internal spring in the pusher was loose.No other visual anomalies were discovered on the inserter shaft.As stated in the instruction for use (ifu): place gentle tension on the suture and unthread the shaft by rotating the shaft with backwards tension in a counter-clockwise direction.Once unthreaded, completely remove the shaft and trim the excess suture.Possible root cause for the broken anchor could be excessive tension on the suture coupled with levering during the unscrewing of the inserter from the implant.This failure could be attributed to user technique, however a specific root cause could not be determined.A non-conformance search was performed for this part 210818 lot l790088 combination and no nonconformance 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 to monitor the extent to 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: 7930826
• Report Number: 1221934-2018-54795
• Device Sequence Number: 19348883
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 210818
• Device Lot Number: L790088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 10/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other