MAUDE Adverse Event Report: DEPUY MITEK LLC US HEALIX TRANSTEND TI ANC W/OC; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 222260

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2018

Event Type  malfunction  

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).The expiration date is not currently available.(b)(6).

Event Description

It was reported by the distributor that during a shoulder arthroscopy surgery (bankart repair), the anchor kept attached to its insertor.It was impossible to deliver it after the screwing.1 part involved.Additional information received on (b)(6) 2018: no patient impact and there was no delay in procedure.

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.H10 additional narrative: 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 inspected.The complaint can be confirmed.A visual inspection revealed that the anchor was free of any gross visual defects.It was observed that the suture was stuck within the handle.It is possible that the suture is slightly tangled and has caused the anchor to become stuck to the inserter.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.Udi: (b)(4) - incomplete.The expiration date is not currently available.

• Brand Name: HEALIX TRANSTEND TI ANC W/OC
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7642115
• MDR Text Key: 112553044
• Report Number: 1221934-2018-52517
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705008063
• UDI-Public: 10886705008063
• Combination Product (y/n): N
• PMA/PMN Number: K102298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 222260
• Device Lot Number: L689918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Date Manufacturer Received: 11/05/2018
• Patient Sequence Number: 1
• Patient Age: 38 YR