MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORCI SCRW 7MM(7MM HD)X20MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	7207916
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the screw broke during insertion.A backup device was available to complete the procedure without delay or patient impact.
Additional Manufacturer Narrative
Visual assessment of the screw confirmed the complaint of breakage.Approximately 4mm¿s of the distal threads have broken off.The broken piece/pieces were not returned for examination.The remaining screw was returned in two pieces.The screw has broken at the head and has split length wise.Dimensional assessment is prohibitive due to the screws condition.With the limited clinical details provided regarding site preparation and patient bone quality a root cause cannot be determined.A review of the device history record was performed which confirmed no inconsistencies.

• Brand Name: BIORCI SCRW 7MM(7MM HD)X20MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6841465
• Report Number: 1219602-2017-01077
• Device Sequence Number: 60246
• Product Code: MAI
• UDI-Device Identifier: 03596010000897
• UDI-Public: (01)03596010000897(17)210617(10)50606836
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K032224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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: 06/17/2021
• Device Model Number: 7207916
• Device Catalogue Number: 7207916
• Device Lot Number: 50606836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR