MAUDE Adverse Event Report: ACUMED, LLC; PLATE, FIXATION, BONE

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

Patient Problem Implant Pain (4561)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not received for evaluation.Manufacturing and inspection records could not be reviewed as device information is unknown.Based on the information received, the root cause could not be determined.

Event Description

(report 48 of 56) in the article "an alternative treatment for degenerative triangular fibrocartilage complex injuries with distal radioulnar joint instability: first experience with 48 patients " by shaer, s.A., et al, the authors described the outcomes of a novel technique for restoring distal radioulnar joint (druj) stability due to ulnar impaction syndrome using a distally based extensor carpi ulnaris (ecu) tendon strip combined with ulnar shortening osteotomy (uso) in 48 patients.This was a retrospective study using routinely collected data on a consecutive cohort of patients who underwent uso combined with a distally based longitudinal ecu strip between 2012 and 2020 in their institution.A total of 48 patients with a mean age of 37 years (sd 13, range 17-62) were included.After a brachial plexus block or general anaesthesia, a tourniquet was placed on the upper arm.A longitudinal incision on the dorso-ulnar side of the forearm was made, taking care to preserve the dorsal sensory branches of the ulnar nerve.An oblique osteotomy was performed, and the ulna was shortened by several millimeters according to the preoperative planning.The preoperative planning was carried out using pronated grip views and the ulna variance was assessed with the perpendicular method.The surgeons performed the osteotomy using an external cutting device (acumed, hillsboro, or, usa or a different manufacturer).The plate was placed on the dorsal surface of the distal ulna shaft.After performing the uso, druj stability was reexamined by the same surgeon as before the uso using a ballottement test and was compared with the unaffected side.In cases of persistent instability, an ecu strip reconstruction was added.Approximately 2 cm proximal from the ulnar neck, the ecu was split longitudinally up to a length of one-third of the forearm.At the level of the druj, a suture anchor (different manufacturer) was placed at the dorso-ulnar area of the radius.They used the radial-sided ecu strip with a diameter of 3-4 mm and a length of approximately 12-14 cm to stabilize the druj.The ecu tendon strip was transposed first proximal to the ulnar head under the extensor digiti minimi flush over the bone towards the distal radius, anchoring the strip here but not too tight.The next transposition of the ecu strip was made at the distal level of the ulnar head, with the strip being tunneled flush over the tfcc complex towards the ulnar styloid.At this level, an incision was made at the palmar side of the ecu sheath and the tendon strip was passed inside the ecu sheath to its origin.Before suturing the ends together, they checked that the loop fitted well and was nearly tight against the ulnar head and around the druj but was not yet pulled to maximal tightness.The next step was to suture the ecu strip near the bone anchor and to fix it as tight as possible to the anchor and distal radius.The last step was suturing the proximal end with non-absorbable sutures.The wound was closed with vicryl, monocryl or prolene (different manufacturer) in layers.The following complications were reported: - 1 scar tenderness treated with expectant management -3 scar tenderness treated with analgesics - 1 scar tenderness treated with hand therapy and splint - 1 ulnar nerve sensibility disturbances including numbness treated with expectant management - 2 ulnar nerve sensibility disturbances including numbness treated with hand therapy and splint -1 with pain only during pronation treated with analgesics - 4 with ecu tendinitis treated with analgesics - 1 with ecu tendinitis treated with hand therapy - 1 with ecu tendinitis treated with hand therapy and splint - 1 with ecu tendinitis treated with corticosteroid injection -1 with ecu tendinitis treated with dry needling - 1 with ecu subluxation treated with hand therapy and splint -2 with oedema treated with tubigrip support and hand therapy - 36 with plate irritation resulting in removal there are 56 related report numbers for this event 3025141-2024-00202 through 3025141-2024-00257.

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUMED, LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass road; hillsboro 97124
• MDR Report Key: 18861978
• MDR Text Key: 337184663
• Report Number: 3025141-2024-00249
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2024
• 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
• Patient Outcome(s): Other