MAUDE Adverse Event Report: CONMED LARGO XACTPIN GRAFT PASSING GUIDE PIN STER; BIT, SURGICAL

Catalog Number C8677S

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

Note: this report is being resubmitted following an unsuccessful submission attempt on 2021-08-12 due to a system error.The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.Device not yet received.

Event Description

The sales representative reported on behalf of the customer that the device, c8677s, was being used on (b)(6) 2021 during an anterior cruciate ligament repair procedure and the tips broke during use.We were able to retrieve all the pieces from the patient.Probably a 15 minute delay." the patient had hard bone and they may have scived in the femoral canal.The stryker pin driver was not holding the pins correctly and letting them slip instead of advancing.The stryker pin driver will be listed as a concomitant device.After further assessment it was found, the procedure was completed.There was no injury or impact to the (b)(6) year old, 170 pound, male patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Customer event ¿the tips broke during use¿ was confirmed based on photographic evidence and device evaluation.The evaluation of returned used device found guide pin broken off at the etch line.Broken guide pins are three inch long and were return for evaluation.Critical dimensions were inspected and could not find any discrepancies.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 was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of one complaint, regarding two devices, for this device family and failure mode.During this same time frame (b)(6) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.001.Per the instructions for use, the user is advised the following: to avoid damage or breakage during use, do not use excessive force on xactpin graft passing guide pin - sterile.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the device, (b)(4) , was being used on (b)(6) 2021 during an anterior cruciate ligament repair procedure and ¿the tips broke during use.We were able to retrieve all the pieces from the patient.Probably a 15 minute delay." the patient had hard bone and they may have scived in the femoral canal.The stryker pin driver was not holding the pins correctly and letting them slip instead of advancing.The stryker pin driver will be listed as a concomitant device.After further assessment it was found, the procedure was completed.There was no injury or impact to the 17 year old, 170 pound, male patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: XACTPIN GRAFT PASSING GUIDE PIN STER
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• MDR Report Key: 12387393
• MDR Text Key: 268790296
• Report Number: 1017294-2021-00323
• Device Sequence Number: 1
• Product Code: GFG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C8677S
• Device Lot Number: 1162064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Date Manufacturer Received: 08/30/2021
• Patient Sequence Number: 1
• Treatment: STRYKER PIN DRIVER; STRYKER PIN DRIVER; STRYKER PIN DRIVER
• Patient Age: 17 YR
• Patient Weight: 77