MAUDE Adverse Event Report: CONMED CORPORATION 4.5MM POPLOK SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	CKP-4500
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The alleged broken ckp-4500 is not expected to be returned for evaluation and review.This complaint of broken device is unable to be verified and a root cause cannot be determined.A device history review found a non-conformance against this device; however, the device was reworked and passed inspection.Per discussion with engineering, this non-conformance had no effect on this failure mode.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following: precautions: ensure proper selection of bone punch according to anchor size selection.Avoid lateral loading while inserting the poplok knotless suture anchor.Maintain proper alignment during insertion of the anchor and disengagement of the driver a determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the ckp-4500, 4.5mm poplok suture anchor, device was being used during a procedure on (b)(6) 2019 and the device is reported as having "split in to two pieces as it was being inserted".Another device was used to complete the procedure.Further information was requested for assessment; however, no further response has been received from the reporter.Previously this device has had a filing within two-years for injury based on breakage.This report is being raised on the basis of injury due to a report of breakage during use and no further information being available for assessment.

• Brand Name: 4.5MM POPLOK SUTURE ANCHOR
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 8439332
• Report Number: 1017294-2019-00039
• Device Sequence Number: 1063006
• Product Code: MBI
• UDI-Device Identifier: 20845854014100
• UDI-Public: (01)20845854014100(17)240113(30)1(10)990138
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K091549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2024
• Device Model Number: CKP-4500
• Device Catalogue Number: CKP-4500
• Device Lot Number: 990138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/21/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other