MAUDE Adverse Event Report: DEPUY MITEK LLC US HEALIX AWL -NS; BONE AWL

Model Number	222223
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).The lot number was unknown.Investigation summary: according to the information received, it was reported that theatre nurses have asked for a healix awl to be re-etched.The product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received provided by customer.The complaint device was received and evaluated.Visual observation revealed that the sharp tip at the distal end appears to be flattened.Also, the distal part was dull to the touch and found with scratches.The healix appeared to be slightly worn.Finally, the laser line was faded.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.The possible root 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.As per ifu- 108410 the precautions for this type of device consist 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.
Event or Problem Description
It was reported by the affiliate in (b)(6) that the healix awl device needed to be re-etched.During in-house engineering evaluation, it was determined that the sharp tip at the distal end appeared to be flattened.There was no procedure nor patient involvement reported.No additional information was provided.

• Brand Name: HEALIX AWL -NS
• Common Device Name: BONE AWL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12059233
• Report Number: 1221934-2021-01974
• Device Sequence Number: 19708629
• Product Code: LXH
• UDI-Device Identifier: 10886705007707
• UDI-Public: 10886705007707
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2021

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: 222223
• Device Catalogue Number: 222223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1