MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN SUSPENSORY FIXATION DEVICE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoesthesia (2352); Hyperesthesia (4420)

Event Date 09/01/2003

Event Type  Injury  

Manufacturer Narrative

(b)(4).Gobbi a, tuy b, mahajan s, panuncialman i.Quadrupled bone-semitendinosus anterior cruciate ligament reconstruction: a clinical investigation in a group of athletes.Arthroscopy.2003 sep;19(7):691-9.Doi: 10.1016/s0749-8063(03)00685-6.

Event Description

It was reported that on literature review ¿quadrupled bone-semitendinosus anterior cruciate ligament reconstruction: a clinical investigation in a group of athletes¿, after surgery with an endobutton, 8 patients experienced persistent hypoesthesia, at 12 months follow-up.No further information is available.

Manufacturer Narrative

H10: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.No further medical assessment is warranted at this time.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.H6: updated codes.

• Brand Name: UNKNOWN SUSPENSORY FIXATION DEVICE
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 12471162
• MDR Text Key: 271444213
• Report Number: 1219602-2021-01995
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention