MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 8X30MM STRL BX 1; SCREW, FIXATION, BONE

Model Number	7207561
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tibial fixation the biorci screw broke while it was screwing into the bone.The broken piece was retrieved using a grasper.The procedure was successfully completed without a significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3,h6: one 7207561 sterile biorci 8x30mm screw was used for treatment, was not returned for evaluation.Due to product unavailability, the evaluation was limited.If further information becomes available the complaint may 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.Review of instruction for use (ifu) documentation confirms instructions, precautionary statements and recommendations for proper use of product.Prep per the ifu recommendation is critical for ease of insertion and successful anchoring.Per ifu 1060635: ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Read these instructions completely prior to use.The starter must be utilized with the biorci screws to minimize screw breakage during insertion.Prior to use inspect the tip of the driver.If tip flaring is apparent do not use the driver.Excessive force should not be placed on the delivery instrument.If hard bone is encountered, the biorci tap should be used.¿ complaint history review indicated a similar allegation for the lot number reported.Batch review did not indicate a failure that supported the allegation.Product met specifications upon release to distribution.

• Brand Name: SCR BIORCI 8X30MM STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9926978
• Report Number: 1219602-2020-00598
• Device Sequence Number: 2741752
• Product Code: HWC
• UDI-Device Identifier: 03596010426239
• UDI-Public: 03596010426239
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 05/04/2020

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: 04/10/2023
• Device Model Number: 7207561
• Device Catalogue Number: 7207561
• Device Lot Number: 50762637
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 04/05/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR