MAUDE Adverse Event Report: CONMED CORPORATION 3.5MM POPLOK SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	CKP-3500
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer complaint that the "wings were broken" is confirmed.An examination of the returned used device, item ckp-3500 found the driver assembly bent, the anchor has a broken wing and still attached from the shaft.The device trigger was pressed all in.A visual evaluation was performed per assembly print for the ckp-3500 and no issues were noted with the driver.This is a technique dependent device and the most likely cause of this issue is user related.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue.A two-year lot history review shows this is the only complaint for this lot number and failure mode.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Per the ifu, the user is advised: to avoid lateral loading while inserting the poplok knotless suture anchor.Maintain proper alignment during insertion of the anchor and disengagement of the driver.Proper orientation and alignment of instruments is important during implantation of the poplok knotless suture anchor to minimize possible breakage of the anchor.Breakage of the poplok knotless suture anchor is possible if the bone punch is not inserted to the proper depth, the poplok knotless suture anchor is not properly aligned with the pilot hole, or the poplok knotless suture anchor inserter is used for prying.This product will continue to be monitored via returns and complaint system.
Event or Problem Description
The customer reported an issue with the 3.5mm poplok suture anchor, item # ckp-3500, lot # 988733 that occurred on (b)(6) 2019 during an arthroscopic shoulder rotator cuff repair involving a (b)(6) year old male.It was reported after making pilot hole using 3.5mm poplok punch and placing until the distal depth mark, the surgeon passed sutures through the poplok anchor using suture loading tab and inserted the anchor head into the pilot hole.When tensioning sutures, the wings were broken and the surgeon removed them from a patient's body.A complaint product is available for return without the broken pieces as the broken pieces were disposed of at a hospital.It is indicated that there was no impact or injury to the patient and the procedure was successfully completed using another poplok with a reported 5- minute delay.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 3.5MM POPLOK SUTURE ANCHOR
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• MDR Report Key: 8721906
• Report Number: 1017294-2019-00073
• Device Sequence Number: 11268034
• Product Code: MBI
• UDI-Device Identifier: 10845854013854
• UDI-Public: (01)10845854013854(17)240103(30)1(10)988733
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K091549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2024
• Device Catalogue Number: CKP-3500
• Device Lot Number: 988733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR