MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES HR004, S/M ALEXIS ORTHO PROT 5/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	HR004
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided by the complainant.Visual inspection confirmed the complainant¿s experience of sheath tore.Based on the description of the event and provided photograph, it is likely that the reported event was caused by an instrument that came in contact with the sheath during the procedure.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This is a combined initial and final report.
Event or Problem Description
Name of procedure being performed: total anterior hip replacement.Detailed description of event: the surgeon pointed out that the unit was torn.This was noted about half way through the case.The surgeon continued to use the device and completed the case with the same unit.The sheath did not particulate and there were no missing pieces.The rep was present for the case.No patient injury occurred and the device was discarded after the case by the hospital.A photograph is available.Patient status: no patient injury occurred associated with the complaint event.Type of intervention: no intervention was performed and the surgeon finished the case with the same device.

• Brand Name: HR004, S/M ALEXIS ORTHO PROT 5/BX
• Common Device Name: RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8923687
• Report Number: 2027111-2019-00567
• Device Sequence Number: 19406927
• Product Code: KGW
• UDI-Device Identifier: 00607915123185
• UDI-Public: (01)00607915123185(17)211115(30)01(10)1342113
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2019

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 Expiration Date: 11/15/2021
• Device Model Number: HR004
• Device Catalogue Number: 101428801
• Device Lot Number: 1342113
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR