MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 7X20 7MM HEAD STERILE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	7207686
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgical procedure the screw broke vertically, all parts were removed from the patient without damage to the same.
Additional Manufacturer Narrative
Examination was not possible, as the device was not returned.The investigation could not draw any conclusions about the reported event without the return of the device.Evaluation codes updated.

• Brand Name: SCR BIORCI-HA 7X20 7MM HEAD STERILE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7133840
• Report Number: 1219602-2017-01567
• Device Sequence Number: 11094871
• Product Code: MAI
• UDI-Device Identifier: 03596010459909
• UDI-Public: (01)03596010459909(17)211220(10)50637522
• Combination Product (Y/N): N
• PMA/510(K) Number: K002274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018

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: 12/20/2021
• Device Model Number: 7207686
• Device Catalogue Number: 7207686
• Device Lot Number: 50637522
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 02/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR