MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ELBOW CONNECTOR BAR; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Catalog Number	7210572
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during shoulder scope the surgery center had issues with their shoulder stabilization kits.The coban that comes inside the packaging is worthless.It shreds as soon as it is used.It was noticed at the beginning and no delay were reported.A competitor device was used to complete the procedure.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device, which was used in a procedure, was not returned for evaluation.A relationship between the device and the reported incident could not be confirmed.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found other related failures.All risks have been adequately identified and no changes are required at this time.A device labeling / instruction for use review was performed and indicated the instructions for use includes recommendations, instructions and precautionary statements for proper use of the product.Factors that are known to contribute to the alleged fault / failure may include a material failure.If the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.

• Brand Name: ELBOW CONNECTOR BAR
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10116898
• Report Number: 1643264-2020-00288
• Device Sequence Number: 16984517
• Product Code: FWZ
• UDI-Device Identifier: 03596010513823
• UDI-Public: 3596010513823
• Combination Product (Y/N): N
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 7210572
• Device Lot Number: D192461
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 08/31/2020
• 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: Required Intervention