MAUDE Adverse Event Report: DEPUY MITEK LLC US VERSALOK THREADER TAB *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	210800
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Tissue Damage (2104); Foreign Body In Patient (2687)
Date of Event	06/11/2018
Type of Reportable Event	Serious Injury
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)(4).
Event or Problem Description
The customer reports that the post surgery radiography of the rotator cuff repair with the double row technique ( under locoregional anesthesia ) showed a grubbing-up of the anchor which was localised in the subacromial space.During the surgery, the anchor on the lateral side was impacted and locked with a gun.The surgical suture of the cuff was removed.A new surgery occured the following morning under general anesthesia with a simple row technique.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.The anchor was received with the cut orthocords still attached.By visual inspection, the anchor appeared to be free of any gross visual defects.Per the ifu, depuy mitek anchors are designed to lock into cortical or cancellous bone.Bone stock must be adequate to allow proper and secure anchor placement.Incomplete insertion, overtensioning or poor bone quality may result in anchor pullout.It is possible that the surgeon did not adequately tap the anchor into the bone hole, or adequately prepare the bone hole for insertion.However, given the information provided we cannot discern a definitive root cause for the reported failure.A non-conformance search was conducted to investigate any defects during production identified that may contribute to the complaint condition.No non-conformance was identified for this part-lot number 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.Device history lot: no non-conformance was identified for this part/lot number combination.Udi: (b)(4).
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).
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The customer reports that the post surgery radiography of the rotator cuff repair with the double row technique (under locoregional anesthesia) showed a grubbing-up of the anchor which was localised in the subacromial space.During the surgery, the anchor on the lateral side was impacted and locked with a gun.The surgical suture of the cuff was removed.A new surgery occured the following morning under general anesthesia with a simple row technique.Additional information from affiliate: there was no delay.A revision occured the next day (locoregional anesthesia, general anesthesia) : 30-40 minutes, without problem, but the surgical technique was changed, no modification of the post-op instructions.The constraints for the patient : feeling of failure, a new hospitalization, a new anesthesia so a high risk.No risk increased.

• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7695792
• Report Number: 1221934-2018-53782
• Device Sequence Number: 1451860
• Product Code: HWC
• UDI-Device Identifier: 10886705001163
• UDI-Public: (01)10886705001163(10)L513142(17)200831
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/20/2018

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: 08/31/2020
• Device Catalogue Number: 210800
• Device Lot Number: L513142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 08/17/2018; 09/12/2018; 11/09/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 08/28/2018; 10/08/2018; 11/12/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention