MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A0G11, STLTH FIBRA INSERT SZ 1 F/F 10/BX; DXC

Model Number	A0G11
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Please see the attached report 'amr2017-03' with pictures: (on (b)(6) 2017: during preparation or surgery) a medical staff tried to attach the insert to a clamp, however; the insert was broken easily.Another package of the insert (same lot#) was used for procedure.This event didn't affect the patient.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon visual inspection, engineering confirmed that one of the tabs located on the proximal end of the insert was damaged, which would affect the unit's ability to attach to the clamp.It is likely that the root cause of the event was improper technique during installation of the insert, as this can cause damage to the tabs and make it unable to remain attached to the clamp.The instructions for use (ifu) states, " to place an insert, slide the tip of the clamp into the closed end of the insert.Press the insert onto the clamp by applying pressure at the tip and sliding the thumb across the insert towards the proximal end." applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary to ensure the performance and safety of its products.

• Brand Name: A0G11, STLTH FIBRA INSERT SZ 1 F/F 10/BX
• Common Device Name: DXC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6380527
• Report Number: 2027111-2017-01290
• Device Sequence Number: 674820
• Product Code: DXC
• UDI-Device Identifier: 00607915114794
• UDI-Public: (01)00607915114794(17)200824(30)01(10)1253684
• Combination Product (Y/N): N
• PMA/510(K) Number: K950492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2017

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: Other
• Device Expiration Date: 08/24/2020
• Device Model Number: A0G11
• Device Catalogue Number: 100736601
• Device Lot Number: 1253684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2017
• Supplement Report FDA Received Date: 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1