MAUDE Adverse Event Report: CONMED 4.5MM POPLOK SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES; FIXATION ANCHOR, SOFFT TISSUE, NON-BIODEGRADABLE

Model Number	CKP-4502
Medical Device Problem Codes	Material Fragmentation (1261); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The used device was returned to conmed for evaluation.Visual inspection of the device found one of the anchor's wings had broken off and the anchor and suture were still attached to the driver shaft.The device's trigger was fully pressed in.This is a technique dependent device.A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture.A review of this lot number showed no other complaint for this lot product and event description.A two-year review of complaint history revealed 2 other similar adverse events, with 2 devices, for this product family and failure mode.During this same time frame, (b)(4) devices have been manufactured and shipped worldwide, making the rate of occurrence for the failure of a detached piece of the device that was not retrieved (b)(4) percent, if all complaints were confirmed.The instructions for use advises the user of the following.Proper selection and placement of the implant are important considerations in the successful utilization of this device.Proper orientation and alignment of instruments is important during implantation of the poplok knotless suture anchor to minimize possible breakage of the anchor.Avoid lateral loading while inserting the poplok knotless suture anchor.Maintain proper alignment during insertion of the anchor and disengagement of the driver.Do not deploy device, by squeezing trigger, until proper implant placement and suture tension is achieved.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The conmed sales representative reported that during a rotator cuff repair, the ckp-4502 anchor did not deploy properly and could not be removed from the driver shaft.The surgeon forcefully removed the driver and anchor from the patient.Inspection of the anchor showed one wing had deployed, and one wing was missing.The procedure was completed as a single row repair, rather than a double row, with a 10 minute surgical delay.No patient injury was reported.Evaluation of the returned device confirmed a wing was not attached to the anchor or returned for evaluation; therefore, its location is unknown.This report is being raised on the basis of the unknown location of a non-biodegradable piece of a device.

• Brand Name: 4.5MM POPLOK SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES
• Common Device Name: FIXATION ANCHOR, SOFFT TISSUE, NON-BIODEGRADABLE
• Manufacturer (Section D): CONMED; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 7639654
• Report Number: 1017294-2018-00104
• Device Sequence Number: 16591405
• Product Code: MBI
• UDI-Device Identifier: 20845854014124
• UDI-Public: (01)20845854014124(17)200401(30)1(10)916369
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K091549
• 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
• Report Date (Section B): 06/26/2018

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?: No
• Operator of Device: Other
• Device Expiration Date: 04/01/2020
• Device Model Number: CKP-4502
• Device Catalogue Number: CKP-4502
• Device Lot Number: 916369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 75