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

Model Number	7207560
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, after passing the graft through the tunnels, the medical staff proceeded to fix the graft to the femur with an "8 x 25 mm biorci screw".However, it was not achieved because when trying to fix the screw to the cortex, it was noted that the screwdriver rotated on the same axis of the screw but without the desired purpose.Another attempt was made to replace the screw without success; thus the screw was removed from the patient.The procedure was successfully completed without significant delay using a 9 x25 mm biorci screw.No 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
H10 h3, h6: one 7207560 scr biorci 8x25mm strl bx 1, has not retuned for evaluation.Without the reported product, a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.The information provided states: ¿after passing the allograft through the tunnels, the medical staff proceeded to fix the graft to the femur with an 8 x 25 mm biorci screw", procedure was completed with a 9 x 25 mm bio screw.An exact root cause cannot be determined with confidence without the pertinent clinical details; however, factors that could have contributed to the reported event include: not preparing the insertion site as required by the instructions for use.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.Complaint history review indicated no similar allegations for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.
Event or Problem Description
It was reported that during an anterior cruciate ligament reconstruction surgery, after passing the allograft through the tunnels, the medical staff proceeded to fix the graft to the femur with an "8 x 25 mm biorci screw".However, it was not achieved because when trying to fix the screw to the cortex, it was noted that the screwdriver rotated on the same axis of the screw but without the desired purpose.Another attempt was made to replace the screw without success; thus the screw was removed from the patient with a clamp.The procedure was successfully completed without significant delay using a 9 x 25 mm biorci screw into the same bone hole.No other complications were reported.

• Brand Name: SCR BIORCI 8X25MM STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10428806
• Report Number: 1219602-2020-01287
• Device Sequence Number: 3273702
• Product Code: HWC
• UDI-Device Identifier: 03596010426222
• UDI-Public: 03596010426222
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2024
• Device Model Number: 7207560
• Device Catalogue Number: 7207560
• Device Lot Number: 50830193
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 70