MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TBD; COMPONENT, TRACTION, NON-INVASIVE

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported that after a bucket-handle tear of the medial meniscus involving 90% of the peripheral attachment repair with 5 acufex t-fix meniscal repair system, the patient presented a painless medial left knee mass at postoperative week 12.Aspiration of the mass and an mri revealed a meniscal cyst.The cyst was excised and contained one of the t-fix implanted.Histologic examination of the cyst confirmed the preoperative diagnosis of a synovial cyst.The outcome of the patient is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The investigation was limited to the information provided as the unknown t-fix devices unknown lot numbers will not be returned for examination.The investigation could not draw any conclusions about the reported event with the limited information provided.A review of the manufacturing and complaint records was performed which identified no additional complaints of this nature for this device family outside of the scope of the article.The risk management documentation was also reviewed and found to contain this failure mode within the risk file, no updates are required.The article recognized a painless medial joint cyst formation approximately 3 months post all-inside meniscal repair using 5 double-armed acufex t-fix sutures in a 16 year old with a traumatic bucket tear.Reportedly, the exact cause of the meniscal cysts was unclear; however, it was generally accepted that ¿trauma-induced intrasubstance meniscal cystic degeneration initiates the process¿.It was documented that a ¿1 cm cyst pedicle was found incorporating four of the t-fix devices¿ which was excised and histology confirmed the diagnosis of synovial cyst.The article recognized cyst formation to be a rare complication that may be mitigated by placing the t-bar external to the joint (as not to allow a tract for synovial fluid), maintain a radial configuration, and place sutures at least 4-5mm apart to minimize the size and number of potential intrameniscal tracts which could coalesce and facilitate cyst formation.Although a copy of an mri was included in the article, it did not provide insight into the root cause of the cyst formation.No other patient specific supporting documentation was provided; therefore, a thorough medical investigation could not be performed.The patient impact beyond the reported non-symptomatic synovial cyst formation and excision could not be definitively determined; however, per the article, the¿diagnostic arthroscopy revealed nearly complete healing¿ of the meniscus with only a ¿1-cm incomplete, stable posteroinferior tear remained¿.No further medical assessment could be rendered.The report numbers of the devices mentioned are: 1219602-2019-01638, 1219602-2019-01639, 1219602-2019-01640 and 1219602-2019-01641.

• Brand Name: TBD
• Type of Device: COMPONENT, TRACTION, NON-INVASIVE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9520557
• MDR Text Key: 173293074
• Report Number: 1219602-2019-01640
• Device Sequence Number: 1
• Product Code: KQZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 02/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR