MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2019-05-06 for HUNTER TENDON UNK manufactured by Wright Medical Technology, Inc..
[144177021]
Literature citation: mccleave. Ulnar nerve injury after flexor tendon grafting. The journal of hand surgery. 2016; 21: 425-427. Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[144177022]
Allegedly, in an article written by mccleave et al titled "ulnar nerve injury after flexor tendon grafting" it was reported that the patient underwent a two-stage tendon reconstruction and developed a low ulnar nerve palsy postoperatively. Exploration found that the tendon graft was passing through guyon's canal and that the ulnar nerve was divided. A (b)(6)-year-old female left hand dominant chef cut her finger with a knife and initially had her finger sutured by her local doctor. She was referred six weeks later to a hand surgeon at another institution with a loss of small finger flexion. A diagnosis of a ruptured flexor digitorum profundas (fdp) in zone two was made and the patient then had a two-stage tendon reconstruction using a split flexor carpi radialis (fcr) tendon with surgery two month later. The patient then had a tenolysis nine months later to improve her flexion. The patient had noticed numbness in the distribution of the ulnar nerve immediately after her first operation. A nerve conduction study was performed 12 months after the initial surgery and showed a severe ulnar nerve neuropathy at the level of the wrist. An ultrasound stated that the fdp tendon to the 5th digit was intact but thinner than the contralateral side. A palmar mass was noted on the volar aspect of the tendon and it was thought that this represented the old ruptured tendon. No mention was made of the tendon position within the hand and wrist or about the ulnar nerve. She was subsequently referred to me for an opinion. Clinically a small volar wrist scar was noted. She had an ulnar claw hand deformity, severe ulnar innervated intrinsic muscle wasting and numbness over the volar aspect of the small and ulnar half of the ring finger. A low ulnar nerve injury within guyon's canal was diagnosed. The small finger tendon graft had good flexion but restricted extension. The patient underwent an exploration that exposed the ulnar nerve in guyon's canal with distal and proximal extension. It was noted that the tendon graft was passing through guyon's canal and able to flex the small finger. The ulnar nerve was divided at the level of the trifurcation. A neuroma was present on the proximal nerve. Fig. 1 shows the tendon graft passing through guyon's canal and the divided ulnar nerve. The tendon graft was divided proximally and rerouted under the distal neurovascular bundles and through the carpal tunnel. It was attached to the ring finger fdp tendon with a pulvertaft weave. Three sural nerve grafts were used to reconstruct the ulnar nerve. The patient has now been followed for 18 months and the small finger has a full active range of motion. Two point discrimination in the ulnar nerve distribution measured 8-10 mm and ulnar innervated intrinsic function is graded at m3.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2019-00058 |
| MDR Report Key | 8583552 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2019-05-06 |
| Date of Report | 2019-04-11 |
| Date of Event | 2015-06-12 |
| Date Mfgr Received | 2019-04-11 |
| Date Added to Maude | 2019-05-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR MATTHEW PARRISH |
| Manufacturer Street | 1023 CHERRY RD |
| Manufacturer City | MEMPHIS TN 38117 |
| Manufacturer Country | US |
| Manufacturer Postal | 38117 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 11576 MEMPHIS ARLINGTON RD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUNTER TENDON |
| Generic Name | PROSTHESIS, TENDON, PASSIVE |
| Product Code | HXA |
| Date Received | 2019-05-06 |
| Model Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 11576 MEMPHIS ARLINGTON RD ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-06 |