MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL, 1.9MM, S, DISPOSABLE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72203856
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff surgery, the expiration dates on the box and the inner pouch did not match.The box was labeled as 02/01/2019 and the inner pouch was labeled as 02/2019.The correct expiration date is 02/04/2019 and the device was used on the patient on (b)(6) 2019.No patient injury or other complications were reported.
Additional Manufacturer Narrative
One 72203856 twist drill reported on.The product was not returned.Information relayed: ¿it was reported that during a rotator cuff surgery, the expiration dates on the box and the inner pouch did not match.The box was labeled as 02/01/2019 and the inner pouch was labeled as 02/2019.The correct expiration date is 02/04/2019 and the device was used on the patient on (b)(6) 2019.No patient injury or other complications were reported.¿ this is a disposable product.The lot number provided was manufactured march 2014.At that point in time the label procedure required only month and year expiration information.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will certainly be revisited.There are no other complaints on file for this manufacturing lot.Final product met specifications upon release to distribution.

• Brand Name: DRILL, 1.9MM, S, DISPOSABLE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8361941
• Report Number: 1219602-2019-00227
• Device Sequence Number: 16444793
• Product Code: MBI
• UDI-Device Identifier: 00885554030129
• UDI-Public: 00885554030129
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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: 02/04/2019
• Device Catalogue Number: 72203856
• Device Lot Number: 50495308
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1