MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN SUSPENSORY FIXATION DEVICE; SCREW, FIXATION, BONE

Catalog Number UNKNOWN

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

Patient Problems Deformity/ Disfigurement (2360); Joint Dislocation (2374); Malunion of Bone (4529)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that on literature review "arthroscopic latarjet: suture-button fixation is a safe and reliable alternative to screw fixation", 1 patient had a bone block malposition leading to subluxation of the graft after using a double endobutton.No further complications were reported.Patients outcome is unknown.No further information is available.

Manufacturer Narrative

H2: additional information ¿h6: health effect - clinical code and health effect - impact code¿ h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no relationship found between the device and the reported event.Insufficient product identification information was provided and thus a complaint history review could not be performed.Insufficient product identification information was provided and thus a manufacturing record review could not be performed.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.Insufficient product identification information was provided, and thus, an instructions for use review could not be conducted.Insufficient product identification information was provided, and thus, a risk management review could not be conducted.Consequently, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images and/or graphs provided in the article have been interpreted within the text; therefore, no further analysis of the images and/or graphs is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.The complaint was not confirmed.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.

• Brand Name: UNKNOWN SUSPENSORY FIXATION DEVICE
• Type of Device: SCREW, 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 Key: 15406895
• MDR Text Key: 299751824
• Report Number: 1219602-2022-01363
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K183232
• Number of Events Reported: 1
• 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: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2022
• 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): Other