MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8402, M ALEXIS O WND PROT/RET 5/BX; PROSTHESIS, FINGER, CONSTRAINED, METAL/POLYMER

Model Number	C8402
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: anp.Detailed description of event: "would like to notify you that an alexis wound retractor cat# c8204.Lot#: 1365929 expiration: 08/18/2022 tore during a procedure." the account manager spoke with and received an email from the customer on 22nov2019.The customer reported that no patient injury occurred.The date of the event was (b)(6) 2019.Limited information was available at the time of reporting.It was unknown what instruments were in use at the time of the event.It was unknown what type of procedure was being performed.The device is available for return.Patient status: no patient injury occurred as a result of the complaint event.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be confirmed.Based on the event description, 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.
Event or Problem Description
Name of procedure being performed: hip procedure - anterior hip arthroplasty.Detailed description of event: "would like to notify you that an alexis wound retractor cat# c8204 lot#: 1365929 expiration: 08/18/2022 tore during a procedure." the account manager spoke with and received an email from the customer on 22nov2019.The customer reported that no patient injury occurred.The date of the event was 21nov2019.Limited information was available at the time of reporting.It was unknown what instruments were in use at the time of the event.It was unknown what type of procedure was being performed.The device is available for return.The account manager forwarded the email to applied medical at the same time as he called in the complaint.Additional information received via email on 26dec2019 from [name] account mgr: "customer stated that surgeon was using alexis-o during a hip procedure.Sharp instruments and/or retractors caused the alexis-o to tear during the procedure.Facility will start carrying alexis ortho to ensure patient safety." additional information received via email on 30dec2019 from [name] account mgr: "case was an anterior hip arthroplasty.'hit with an instrument that caused a slight tear in the opaque material.' item was not defective.The alexis was deployed when the tear occurred.The surgeon using the product was [name].Originally they mentioned that the product was retained.Now they are saying that they don¿t have it.I haven't been able to ascertain whether the device was ever saved in the first place.If i hear anything further on this matter i will pass it along immediately." patient status: no patient injury occurred as a result of the complaint event.Type of intervention: ni.

• Brand Name: C8402, M ALEXIS O WND PROT/RET 5/BX
• Common Device Name: PROSTHESIS, FINGER, CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9468863
• Report Number: 2027111-2019-00665
• Device Sequence Number: 16680921
• Product Code: KWG
• UDI-Device Identifier: 00607915117269
• UDI-Public: (01)00607915117269(17)220818(30)01(10)1365929
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2022
• Device Model Number: C8402
• Device Catalogue Number: 101356201
• Device Lot Number: 1365929
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1