MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 8X25MM STRL BX 1; SCREW, FIXATION, BONE

Catalog Number	7207560
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an unknown surgery, the screw broke while inserted.The procedure was completed with less than 30 minutes delay using other screw (9x25 mm).No patient injury or other complications were reported.
Additional Manufacturer Narrative
One 7207560 sterile biorci 8x25mm screw reported on.Due to unavailability, the allegation could not be fully confirmed.Definitive conclusions, investigation and evaluation were not possible without physical evaluation.If objective evidence becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity include: 1.Use of other than recommended prep instrument size or types.2.Entanglement with guide wire or other instrument.3.Stripping or over-torque.4.Damaged prep instruments.5.Not accounting for taper or larger head to body design.6.Unexpected bone density/condition.Final product met specifications upon release to distribution.

• Brand Name: SCR BIORCI 8X25MM STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8283619
• Report Number: 1219602-2019-00116
• Device Sequence Number: 13498532
• Product Code: HWC
• UDI-Device Identifier: 03596010426222
• UDI-Public: 03596010426222
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K992396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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: 07/31/2020
• Device Catalogue Number: 7207560
• Device Lot Number: 50558221
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1