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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 5.0 ULTRABRAID; STAPLE, FIXATION, BONE

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SMITH & NEPHEW, INC. TWINFIX TI 5.0 ULTRABRAID; STAPLE, FIXATION, BONE Back to Search Results
Catalog Number 72200755
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Loss of Range of Motion (2032)
Event Date 01/01/2022
Event Type  Injury  
Event Description
It was reported that on literature review single pulley double-strand anchor suture fixation of the coronoid process in terrible triad of the elbow injury, 2 patients had an extension lag of 25-30 degrees after an elbow procedure using a twinfix ultra device.The condition did not affect the life quality of the patients.No further information is available.
 
Manufacturer Narrative
H10: internal complaint reference (b)(4).Article: lin, k.C., lai, w.Y., yang, y.P., lin, y.Y., lin, t.W., wang, c.L., & tarng, y.W.(2022).Single pulley double-strand anchor suture fixation of the coronoid process in terrible triad of the elbow injury.Journal of the chinese medical association, 85(2), 222-227.H3, h6: this complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources 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.
 
Manufacturer Narrative
H11: corrected information in d4 (catalog, udi numbers) and g4 (510k).
 
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Brand Name
TWINFIX TI 5.0 ULTRABRAID
Type of Device
STAPLE, 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 Key17808821
MDR Text Key324153762
Report Number1219602-2023-01854
Device Sequence Number1
Product Code JDR
UDI-Device Identifier03596010577986
UDI-Public03596010577986
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K152566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Study,Literature,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/02/2023
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number72200755
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/05/2023
Initial Date FDA Received09/25/2023
Supplement Dates Manufacturer Received11/01/2023
Supplement Dates FDA Received11/02/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Outcome(s) Other;
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