MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL NG HEALIX ALL-IN-ONE AWL; BONE AWL

Model Number	222314
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).The lot number was unknown.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by sales rep that during a rotator cuff repair procedure on (b)(6) 2021, it was observed that the tip on the ng healix all-in-one awl device was blunt, skewed and no longer sharp.It was reported that the device made it difficult to prepare holes on hard bone and remove awls after malleting holes for anchor placement.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional 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: the complaint device was not returned after multiple attempts for device return, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Given that lot number was not provided, the manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.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.
Additional 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.The lot number was unknown on the initial report; and has been updated accordingly.Udi: (b)(4).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 correction narrative: the manufacturer name and manufacturer contact name have been updated to reflect the correct information.
Additional 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 file as appropriate.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual observation confirms the sharp tip at the distal end appears to be flattened, confirming this failure.Also, the distal part was dull to the touch and found with scratches.Finally, the device had wear marks.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.The possible root cause can be attributed this damage 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, this failure can be attributed to normal field wear.However, it cannot be conclusively affirmed.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 mitek, 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
• Common Device Name: BONE AWL
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle MA CH-24 00; SZ CH-2400
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle, MA CH-24-00 ; SZ CH-2400 ; 6013142063
• MDR Report Key: 12699370
• Report Number: 1221934-2021-03134
• Device Sequence Number: 3706545
• Product Code: LXH
• UDI-Device Identifier: 10886705022458
• UDI-Public: 10886705022458
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/14/2021

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 Model Number: 222314
• Device Catalogue Number: 222314
• Device Lot Number: 1903002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 11/16/2021; 12/07/2021; 01/25/2022
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 11/17/2021; 12/08/2021; 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown