MAUDE Adverse Event Report: DEPUY MITEK LLC US NG HEALIX ALL-IN-ONE AWL; BONE AWL

Model Number 222314

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 11/12/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: udi: (b)(4).Investigation summary: according to the information received, it was reported that the tip of a 4.5 healix advance awl is damaged.They noticed it when opening it for a case.The instrument was not used and did not delay the case.The complaint device has not been returned, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos, it was found that the tip was damage due to it was bent.The photo did not provide enough evidence to determine the root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.A manufacturing investigation was performed; as a result, a 100% visual inspection is completed ¿100% visual for tip damage¿ using 10x magnification; also, the parts are visually inspected during the packaging process.A zoomed in view of the tip shows a zigzag condition suggesting the part was twisted back and forth prior to the tip failure; perhaps in a previous procedure.This product has been in the field for more than 3 years, paragon medical asserts that the damage is not likely caused from the manufacturing or packaging process.The potential root cause is mishandling of product, after receiving inspection; quite likely in a previous medical procedure.A manufacturing record evaluation was performed for the finished device lot number:1806001, and no nonconformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

Event Description

It was reported by the sales rep that preoperatively to an unknown surgery on (b)(6)2021, it was observed that the ng healix all-in-one awl device was damaged upon opening its package.During in-house engineering evaluation, it was determined that the tip on the device was bent.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary : according to the information received, it was reported that the tip of a 4.5 healix advance awl is damaged.They noticed it when opening it for a case.The instrument was not used and did not delay the case.The product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received provided by customer.Visual observation confirms the sharp tip at the distal end was flattened, confirming this failure.Also, the distal part and the handle had marks of wear.The healix appeared to be slightly worn.A manufacturing record evaluation was performed for the finished device lot number:1806001, and no nonconformances were identified.The possible route cause can be attributed this damage in the tip when the device might have been dropped or device was tapped against a hard surface accidentally.It is determined that the reusable instrument is worn from repeated use and servicing, this failure can be attributed to normal field wear.However, it cannot be conclusively affirmed.A manufacturing investigation was performed; as a result, a 100% visual inspection is completed ¿100% visual for tip damage¿ using 10x magnification; also, the parts are visually inspected during the packaging process.A zoomed in view of the tip shows a zigzag condition suggesting the part was twisted back and forth prior to the tip failure; perhaps in a previous procedure.This product has been in the field for more than 3 years, paragon medical asserts that the damage is not likely caused from the manufacturing or packaging process.The potential root cause is mishandling of product, after receiving inspection, quite likely in a previous medical procedure.As per ifu: the precautions for this type of device consist of to inspect the condition of the device prior to use.This device can damage, worn or bent; therefore, when this occurs it need to replace.The instrument life is generally determined by the wear or damaged from handling or surgical use.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitkek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: NG HEALIX ALL-IN-ONE AWL
• Type of Device: BONE AWL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 13170802
• MDR Text Key: 289426837
• Report Number: 1221934-2022-00013
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705022458
• UDI-Public: 10886705022458
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 222314
• Device Catalogue Number: 222314
• Device Lot Number: 1806001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1