MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES ALEXIS ® ORTHOPAEDIC PROTECTOR; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	HR004
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, photos of the event unit were provided.Visual inspection confirmed the complainant¿s experience of sheath torn and fragmented.It was also noted that the tear contained jagged edges.Based on the description of the event and the photo provided, it is likely that a sharp object or instrument came into contact with the sheath, resulting in a hole or tear that further propagated during use.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.
Event or Problem Description
Procedure performed: thp anterior approach.Description of event: complaint 1 of 2: (b)(4) - mfr# 2027111-2024-00903.Complaint 2 of 2: (b)(4) - mfr# 2027111-2024-00896.The alexis orthopedic was used according to the ifu.During the procedure the alexis was placed according to the ifu.During the reaming fase of the femur the tooth of the reamer caught up on the alexis sheet.This happens almost standard in the procedure.Theoretically fibers of the sheet could come in contact with the reamer/ femur.During the procedure the alexis was placed according to the ifu.During the reaming phase of the femur the tooth of the reamer caught up on the alexis sheet.This happens in 80% of the procedures.Theoretically fibers of the sheet could come in contact with the reamer/ femur.Due to the angle of the reamer during the anterior approach it's likely to happen the sheet tears.The tear in the sheet for the surgeon is no problem.The wound margins are still very clean.Additional information received from company rep.Via email on 23oct24: attached you will find the photos of cer1.Both descriptions are the same and both happened at the same day and place.One adjustment: i used the word reamer, but i meant broach in the description of the cer.The image is a broach; used to widen the femur for the stem prosthesis.The teeth of the broach catch up on the sheet of the alexis when used.Additional information received from company rep.Via email on 30oct24: not that particulate could be seen, unless it¿s on fiber level, all material was retrieved.Intervention: the tear in the sheet for the surgeon is no problem.The wound margins are still very clean.Patient status: patient is ok.
Event or Problem Description
Procedure performed: thp anterior approach.Description of event: complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).The alexis orthopedic was used according to the ifu.During the procedure the alexis was placed according to the ifu.During the reaming fase of the femur the tooth of the reamer caught up on the alexis sheet.This happens almost standard in the procedure.See pictures of the alexis sheet.Theoretically fibers of the sheet could come in contact with the reamer/ femur.During the procedure the alexis was placed according to the ifu.During the reaming phase of the femur the tooth of the reamer caught up on the alexis sheet.This happens in 80% of the procedures.See pictures of the alexis sheet.Theoretically fibers of the sheet could come in contact with the reamer/ femur.Due to the angle of the reamer during the anterior approach it's likely to happen the sheet tears.The tear in the sheet for the surgeon is no problem.The wound margins are still very clean.Additional information received from company rep.Via email on 23oct24: attached you will find the photos of cer1.Both descriptions are the same and both happened at the same day and place.One adjustment: i used the word reamer, but i meant broach in the description of the cer.The image is a broach; used to widen the femur for the stem prosthesis.The teeth of the broach catch up on the sheet of the alexis when used.Additional information received from company rep.Via email on 30oct24: not that particulate could be seen, unless it¿s on fiber level, all material was retrieved.Intervention: the tear in the sheet for the surgeon is no problem.The wound margins are still very clean.Patient status: patient is ok.
Additional Manufacturer Narrative
No product is being returned for evaluation and no lot number has been provided to applied medical.A follow-up report will be provided upon completion of investigation.

• Brand Name: ALEXIS ® ORTHOPAEDIC PROTECTOR
• Common Device Name: RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 20645713
• Report Number: 2027111-2024-00903
• Device Sequence Number: 7385485
• Product Code: GCJ
• UDI-Device Identifier: 00607915123185
• UDI-Public: (01)00607915123185
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: HR004
• Device Catalogue Number: 101428801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REAMER, BROACH, HOMAN.
• Patient Sex: Unknown