MAUDE Adverse Event Report: CONMED CORPORATION HIP PRESERVATION SYSTEM SWITCHING STICK PACK, QTY 1; ACCESSORIES, ARTHROSCOPIC

Catalog Number HPS-SSP

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

The customer reported that the device, hps-ssp, was being used during a hip arthroscopy procedure on (b)(6) 2021 when "the nitinol guidewire unfortunately snapped whilst in use and a portion broke off.Attempted to remove guidewire tip.Portion was left in the patient.The surgeon did not follow the steps as laid out in previous cases i.E.To use the nitinol guidewire, followed by the switching stick, followed by the portal dilator.The surgeon went straight for the portal dilator in this case." the procedure was completed with no alternate device.There was a 45 minute delay.The (b)(6) male patient had an x ray on an unknown date post-operatively and it was discovered that "the item has moved flush to femoral neck, the surgeon says if it stays in position, no further surgery will be required." this report is being raised on the basis of injury due to the fragment remaining in the patient.

Manufacturer Narrative

Reported event is confirmed.Customer complaint of the nitinol guidewire unfortunately snapped whilst in use and a portion broke off was confirmed.Examination of the returned used device, item hps-ssp found item slightly bent and broken off, broken piece is 0.565 of the inch and was not returned for the evaluation.This is technique dependent device and the most likely cause of this suspected failure is user related.Per the ifu, customer is informed to, exercise care in the use of these devices to minimize side or bending loads.Do not use excessive force on devices, to avoid damage or breakage during use.Avoid unintended contact with other surgical instruments during use to prevent damage or breakage.Inspect devices after use to ensure they have not been damaged.Devices are designed for use by surgeons experienced in the appropriate specialized procedures.It is the responsibility of the surgeon to become familiar with the proper techniques for use.Proper placement of all-suture button and backstop are important considerations in the successful utilization of these devices.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 two complaints, regarding two devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised the following: prior to use, remove all protective packaging and tip protector.Inspect instrument prior to use to ensure they are in good physical condition and function properly.There should be no loose, broken or misaligned parts.Exercise care in the use of these devices to minimize side or bending loads.Do not use excessive force on instrument to avoid damage or breakage during use.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: HIP PRESERVATION SYSTEM SWITCHING STICK PACK, QTY 1
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 11445839
• MDR Text Key: 249696676
• Report Number: 1017294-2021-00115
• Device Sequence Number: 1
• Product Code: NBH
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HPS-SSP
• Device Lot Number: 1126181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Date Manufacturer Received: 04/22/2021
• Patient Sequence Number: 1
• Treatment: SMITH &NEPHEW 1.2M CANNULA SHARP TIP.
• Patient Outcome(s): Other
• Patient Age: 25 YR