MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number UNKNOWN

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

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Internal reference: case (b)(4).Muneta, t., sekiya, i., yagishita, k., ogiuchi, t., yamamoto, h., & shinomiya, k.(1999).Two-bundle reconstruction of the anterior cruciate ligament using semitendinosus tendon with endobuttons: operative technique and preliminary results.Arthroscopy: the journal of arthroscopic & related surgery, 15(6), 618-624.Doi: 10.1053/ar.1999.V15.0150611.

Event Description

It was reported that on literature review ¿two-bundle reconstruction of the anterior cruciate ligament using semitendinosus tendon with endobuttons: operative technique and preliminary results¿ after procedure with an "endobutton drill", two patients had the femoral drilled hole broke requiring a pullout fixation.No further information is available.

Manufacturer Narrative

H3, h6: 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 an isolated event.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 could not be performed.Therefore, 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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.Internal complaint reference: (b)(4).

• Brand Name: UNKNOWN
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12446643
• MDR Text Key: 270530283
• Report Number: 1219602-2021-01914
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• 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: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention