MAUDE Adverse Event Report: CONMED CORPORATION ASSISTARM STERILE KIT FOR SHOULDER AND KNEE

Catalog Number	AA-SK-KIT10
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned by the user facility and no photographic evidence has been provided, therefore; the reported failure could not be verified and a root cause cannot be conclusively determined.A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture.A two-year review of complaint history revealed one other similar complaint for this product family and failure mode.The one other similar complaint is regarding the second patient for this facility and doctor.In that same timeframe, (b)(4) units of this product family have been sold worldwide, making the rate of occurrence of this failure (b)(4) percent, if all complaints were confirmed.It is standard medical practice to inspect equipment prior to use.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The conmed sales representative reported on behalf of an user facility that post 2-hour rotator cuff procedure on (b)(6) 2017, using the aa-sk-kit10, the patient "got nerve palsy from the assist arm bandage." this incident occured to two patient's of dr.(b)(6); the doctor has reportedly not done follow up with this patient.No patient injury was reported.Upon attempts to gather additional information from the sales representative, it was confirmed the reported symptoms were related to radial nerve palsy.It was also stated that the procedure had been completed with no surgical delays.No additional information was provided regarding current patient status or if additional treatment was needed as the "the surgeon doesn't remember everything." this report is being raised on the basis of the reported patient's radial nerve palsy whose status is unknown.
Additional Manufacturer Narrative
Corrected data lot#: "201803211" deleted.Provided lot# incorrect as incident occured on (b)(6) 2017.Expiration date: "29-jan-2022" deleted.Incorrect lot# provided.Unique identifier (udi)# deleted.Incorrect lot# provided.Device manufacture date "21-mar-2018" deleted.Incorrect lot# provided.Change from "a review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture." to "a review of manufacturing documents was not possible as the correct lot number for this product was not made available.".

• Brand Name: ASSISTARM STERILE KIT FOR SHOULDER AND KNEE
• Common Device Name: ASSISTARM STERILE KIT FOR SHOULDER AND KNEE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 7593240
• Report Number: 1320894-2018-00154
• Device Sequence Number: 1799682
• Product Code: FWZ
• UDI-Device Identifier: 20845854043605
• UDI-Public: (01)20845854043605(17)220129(30)1(10)201803211
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 01/29/2022
• Device Catalogue Number: AA-SK-KIT10
• Device Lot Number: 201803211
• 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: 04/30/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other