MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 10X30MM STRL BX 1; SCREW, FIXATION, BONE

Model Number	7207567
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on registry review 2021 new zealand acl registry implant report, one patient required a revision surgery after an acl procedure using one biorci screw device.It is unknown how was the event treated/resolved.Patient outcome is unknown.No further information is available.
Additional Manufacturer Narrative
(b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of the 2021 new zealand acl registry implant record report from new zealand that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

• Brand Name: SCR BIORCI 10X30MM STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15880192
• Report Number: 1219602-2022-01858
• Device Sequence Number: 2518354
• Product Code: HWC
• UDI-Device Identifier: 03596010426284
• UDI-Public: 03596010426284
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K992396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 7207567
• Device Catalogue Number: 7207567
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 11/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown