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

Model Number	HR104
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Procedure performed: anterior hip arthroplasty.Description of event: complaint 1 of 3: (b)(4) - mfr# 2027111-2024-00706; complaint 2 of 3: (b)(4); complaint 3 of 3: (b)(4).Anterior hip arthroplasty.The alexis ortho was placed according to the ifu under the tfl and the sartorius.After removing the alexis ortho at the end of the procedure, there was a tear in the sheath of the alexis ortho.Product test with (name redacted) for an anterior hip arthroplasty at [facility] in [city].The surgeon finished the surgery without complications.The tear in the sheath was first discovered after the surgery.Additional information received from company rep.Via e-mail on 19jun2024: the malfunction occurred in the middle of the or while introducing the acetabular socket in to the pelvic.The regular instruments used for anterior hip arthroplasties were used during this procedure together with the alexis were breacher, reamer, retractors.The instruments were used as normal during anterior hip arthroplasties.We are not sure if the device particulated, the surgeon meant that the alexis particulated and part of the alexis sheath was now implanted on the acetabular socket.But this was just his assumption and was not verified.And i will also file another cer with the same product.We tested three alexis orthos and all three ended up having a hole.Only that in two of those three surgeries we were not aware at what time during the surgery the incident happened.With the cer case that i already filed, we saw the incident happen and therefore we know what caused the tear in the alexis sheath.Intervention: the surgeon finished the surgery without complications.Patient status: the patient is fine.
Event or Problem Description
Procedure performed: anterior hip arthroplasty.Description of event: complaint 1 of 3: (b)(4) - mfr# 2027111-2024-00706; complaint 2 of 3: (b)(4) - mfr# 2027111-2024-00728; complaint 3 of 3: (b)(4) - mfr# 2027111-2024-00726.Anterior hip arthroplasty.The alexis ortho was placed according to the ifu under the tfl and the sartorius.After removing the alexis ortho at the end of the procedure, there was a tear in the sheath of the alexis ortho.Product test with (name redacted) for an anterior hip arthroplasty at [facility] in zürich.The surgeon finished the surgery without complications.The tear in the sheath was first discovered after the surgery.Additional information received from company rep.Via e-mail on 19jun24: the malfunction occurred in the middle of the or while introducing the acetabular socket in to the pelvic.The regular instruments used for anterior hip arthroplasties were used during this procedure together with the alexis were breacher, reamer, retractors.The instruments were used as normal during anterior hip arthroplasties.We are not sure if the device particulated, the surgeon meant that the alexis particulated and part of the alexis sheath was now implanted on the acetabular socket.But this was just his assumption and was not verified.And i will also file another cer with the same product.We tested three alexis orthos and all three ended up having a hole.Only that in two of those three surgeries we were not aware at what time during the surgery the incident happened.With the cer case that i already filed, we saw the incident happen and therefore we know what caused the tear in the alexis sheath.Intervention: the surgeon finished the surgery without complications.Patient status: the patient is fine.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.Based on the description of the event, it is likely that the acetabular cup used in the procedure or a sharp object or instrument came into contact with the sheath, resulting in a hole or tear that further propagated due to the stress the sheath experiences during use.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.

• 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 19671622
• Report Number: 2027111-2024-00728
• Device Sequence Number: 3239294
• Product Code: KGW
• UDI-Device Identifier: 00607915138950
• UDI-Public: (01)00607915138950
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 12/05/2024

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: HR104
• Device Catalogue Number: 101472872
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 12/05/2024
• 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: BREACHER.; REAMER.; RETRACTORS.
• Patient Sex: Unknown