MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1; SCREW, FIXATION, BONE

Model Number	7207557
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl reconstruction surgery, the 7x25 mm biorci screw broke when inserted into the femoral tunnel.All pieces were retrieved from the patient, but it is unknown how.After removal, another screw of the same diameter was used in the same bone hole.Surgery was delayed for less than 30 min.The patient was not harmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H6: one 7207557 sterile biorci 7x25mm 8mm head screw was used for treatment but was not returned for evaluation.Due to product unavailability, investigation and evaluation were limited.If relevant information becomes available, the complaint may be revisited.Factors that may affect device performance include: device ability, surgical ability and surgical site preparation according to instructions for use.Instructions for use confirms instructions, recommendations and precautionary statements for proper use of product.Influences that could compromise product integrity include: 1.Site prep with alternate type or recommended size instruments.2.Not accounting for taper or stepped head to body size difference.3.Entanglement with guide wire or other instrument causing tearing and fractures.4.Use of disproportionate screw size.5.Over torqued or use of force causing stripping, fracture 6.Unexpected bone density/condition.Per instructions for use: ¿read these instructions completely prior to use.The starter must be utilized with the biorci screws to minimize screw breakage during insertion.It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.If using a 7 mm biorci screw with an 8 mm head, it is essential to use a stepped router during drilling in order to provide an adequate space for both the head of the screw and the graft.Excessive force should not be placed on the delivery instrument.Complaint history review indicated no similar allegations for the lot number reported.Dhr/batch/lot review did not indicate a condition or product/procedure failure that supported the allegation.Product met specifications upon release to distribution.No further investigation is warranted at this time.

• Brand Name: SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9302717
• Report Number: 1219602-2019-01399
• Device Sequence Number: 19376198
• Product Code: HWC
• UDI-Device Identifier: 03596010426208
• UDI-Public: 03596010426208
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2020

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: 10/04/2023
• Device Model Number: 7207557
• Device Catalogue Number: 7207557
• Device Lot Number: 50762626
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 11/10/2019
• Supplement Report FDA Received Date: 01/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 70