MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 9X30MM STRL BX 1; SCREW, FIXATION, BONE

Model Number	7207564
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during an acl reconstruction surgery the biorci broke off while it was being inserted into the bone tunnel, all the broken pieces were removed using an artrey instrument.No patient injuries or significant delay reported.Back-up device was available to complete the surgery.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 sterile 9x30mm biorci screw used for treatment, was returned for evaluation.It was confirmed to be a 9x30mm product.The head shows indication that stripping began excess torque with continued rotation after snagging.Threads have been chewed up midway where the body was fractured in half.There were also more jagged edges and a ¿v¿ slice at the distal tip.These types of symptoms are aligned with entanglement of the guide wire.Per instructions for use: ¿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 no similar allegations for the lot number reported.Batch review did not indicate a condition or product/procedure failure that supported the allegation.No root cause related to the manufacturing of this device was confirmed.Product met specifications upon release to distribution.

• Brand Name: SCR BIORCI 9X30MM STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9490114
• Report Number: 1219602-2019-01581
• Device Sequence Number: 1839128
• Product Code: HWC
• UDI-Device Identifier: 03596010426260
• UDI-Public: 03596010426260
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 02/22/2020

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: 7207564
• Device Catalogue Number: 7207564
• Device Lot Number: 50762640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1