MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW, BIOSURE REGENESORB, 6MM X 20MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72204391
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw broke.No patient injury was reported.
Additional Manufacturer Narrative
Due no product return, the complaint could not be confirmed.Definitive conclusions cannot be made without a device to evaluate.Accurate investigation and evaluation are not possible.The product met specifications upon release to distribution.(b)(4).

• Brand Name: SCREW, BIOSURE REGENESORB, 6MM X 20MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7163960
• Report Number: 1219602-2018-00020
• Device Sequence Number: 1736699
• Product Code: MAI
• UDI-Device Identifier: 00885554036671
• UDI-Public: (01)00885554036671(17)200202(10)50644840
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K142948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018

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: 02/02/2020
• Device Model Number: 72204391
• Device Catalogue Number: 72204391
• Device Lot Number: 50644840
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1