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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 8X25 STERILE; SCREW, FIXATION, BONE

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SMITH & NEPHEW, INC. SCR BIORCI-HA 8X25 STERILE; SCREW, FIXATION, BONE Back to Search Results
Model Number 7207678
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/23/2019
Event Type  malfunction  
Manufacturer Narrative
The reported 8x25mm biorci screw, used in treatment, has been returned for evaluation.Visual assessment of the screw confirmed the reported complaint of breakage.Approximately 12mm of the distal threads have broken off and were not returned for examination.Dimensional assessment of the screw major diameter and wall thickness was performed and confirmed to meet print specification.Without the pertinent clinical details regarding graft type, tunnel size and patient bone quality an exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: not using a starter or a tap in hard bone applications.Not preparing the tibial and femoral tunnels in accordance with the accepted surgical technique.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the complaint records was performed, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.
 
Event Description
It was reported that during an acl surgery the biorci had a manufacture defect, it was broken, the device did not broke inside the patient's anatomy.No patient injuries or significant delay reported.Back-up device was available to complete the surgery.Results of investigation have concluded that this unit broke intra-operatively which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand Name
SCR BIORCI-HA 8X25 STERILE
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key9638865
MDR Text Key176664033
Report Number1219602-2020-00140
Device Sequence Number1
Product Code HWC
UDI-Device Identifier03596010459961
UDI-Public03596010459961
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K002274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Physician
Type of Report Initial
Report Date 01/28/2020
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
Device Operator Health Professional
Device Expiration Date03/02/2023
Device Model Number7207678
Device Catalogue Number7207678
Device Lot Number50718204
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/13/2020
Initial Date FDA Received01/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/02/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age28 YR
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