MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN MANUAL INSTR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problems Neuropathy (1983); Pain (1994); Deformity/ Disfigurement (2360); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a right elbow arthroscopy, internal to the patient, the upper jaw grasper failed and broke.This failure caused serious injury and had to be surgically removed via invasive surgery, and necessitated additional invasive surgery to retrieve the broken surgical grasper.Patient suffered physical pain, bodily injury, disability and disfigurement.No additional information was received.

Manufacturer Narrative

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.A review of risk management files found that the reported failure was documented appropriately.A complaint history review concluded this was a repeat issue.Based on the limited information provided the clinical root cause for the reported pain, bodily injury, disability, and disfigurement could not be definitively concluded.The patient¿s activities such as weightlifting and wrestling, a long-standing history of difficulties with his elbow as well as a prior elbow surgical intervention, excess scar tissue as well as other reported operative findings cannot be ruled out as possible contributing factors.The patient impact beyond the reported events cannot be concluded.No further medical assessment can be rendered 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.

Manufacturer Narrative

H2: additional information ¿b5, d2: product code, d4: lot number, udi, catalog number, 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.Insufficient product identification information was provided and thus a manufacturing record review, complaint history review, risk management review, and an instructions for use/device labeling review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A clinical review states that the case reports physical pain, bodily injury, disability and disfigurement.The patient, a professional wrestler was treated in may of 2018 for a left pectoralis tendon rupture.Three months later he was treated for right elbow pain, per medical records there was no specific mechanism of injury, he reported pain while lifting weights and a clicking sound as well.The patient was treated previously in 2008 for elbow subluxation.The operative report was provided for review and confirms the treatment for elbow loose bodies, trochlear groove and capitelliar chondral wear.The operative report details that while grasping one of the last loose fragments the upper jaw of the grasper broke, went down the ulnar aspect of the elbow and was wedged very distally in the ulnar gutter.An open incision was made, ¿in the area of the ulnar nerve and it was not fully certain of the area that the nerve was transposed.¿ with the use of an accessory portal and fluoroscopy images the fragment was able to be retrieved from the patient.The fluoroscopy images have been provided for review and are intraoperative images of the loose body removal and use of the shaver but it cannot be confirmed if they demonstrate the jaw of the grasper.One month later the patient was treated for olecranon bursitis, an arthrocentesis was performed on the right elbow.Two months following the procedure the medical records show the patient had difficulty pinching thumb to pinky finger, closing hand into a fist, and decreased sensation of lateral pinky finger.Three months status post diagnostic arthroscopy of the right elbow the patient was referred to specialist for evaluation of the ulnar nerve due to the continued nerve issues in his hand since surgery, patient reported having trouble with gripping activity, as well as trouble with shaking someone's hand.The medical records also document that following sp release of right ulnar nerve with transposition with axogen tube, the patient lacks return of intrinsic strength in hand or sensation in the fifth finger.Based on the limited information provided the clinical root cause for the reported pain, bodily injury, disability, and disfigurement could not be definitively concluded.The patient¿s activities such as weightlifting and wrestling, a long-standing history of difficulties with his elbow as well as a prior elbow surgical intervention, excess scar tissue as well as other reported operative findings cannot be ruled out as possible contributing factors.The patient impact beyond the reported events cannot be concluded.No further medical assessment can be rendered at this time.There was no relationship found between the device and the reported event.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.

Event Description

It was reported that, during a right elbow arthroscopy, internal to the patient, the upper jaw grasper failed and broke.This failure caused serious injury and had to be surgically removed via invasive surgery on (b)(6) 2018 and necessitated to retrieve the broken surgical grasper.Patient suffered physical pain, bodily injury, disability and disfigurement.Patient recheck incision which is completely closed on 03/06/2019 and there was an injury of ulnar nerve at right forearm level.No other complications were reported.

• Brand Name: UNKN MANUAL INSTR
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 11817124
• MDR Text Key: 250389013
• Report Number: 1219602-2021-01109
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• 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?: No
• Date Manufacturer Received: 10/19/2022
• 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 Number: 1