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..
[144170423]
Literature citation: curran et al. "iatrogenic median nerve compression with a silicone rod: a case report and review of the literature. " plast surg case studies. 2015; 01: 5-6
Patient Sequence No: 1, Text Type: N, H10
[144170424]
Allegedly, it was reported in a literature article by curran et al. Titled "iatrogenic median nerve compression with a silicone rod: a case report and review of the literature" that a case study of a tendon rod used in a two stage flexor tendon reconstruction surgery that caused median nerve damage in the patient. In this case, the second stage of the surgery had not been performed and the device was left in and migrated. A (b)(6) right hand dominant butcher presented to the author's services with a three-month history of acute-onset of paraesthesia in the median nerve distribution of his right hand. The symptoms began after a series of repeated pumping exercises of the hand. The paraesthesia was exacerbated by work and was particularly severe at night. His general practitioner had referred him for nerve conduction studies, which revealed moderately prolonged distal latency with markedly reduced amplitude in the median nerve. He was thus referred to the plastic surgery service for further management. On examination, he had a positive tinel's sign and phalen's sign. It was noted that he had a scar at the proximal phalanx of his little finger and at the wrist on the ulnar aspect. On examination, there was no active flexion of this finger. The patient explained that he had sustained a knife laceration to the little finger five years previously and that both flexor tendons had been divided. He underwent a primary tendon repair of the flexor digitorum profundus (fdp) in his native lithuania. The flexor digitorum superficialis tendon to the digit was not repaired. Unfortunately, the repair ruptured four weeks later and a silicone rod was inserted to facilitate a two-stage reconstruction of the fdp tendon. The patient failed to attend for the scheduled second stage surgery and, shortly afterward, relocated to ireland. The loss of function in the little finger had not concerned him significantly and he was able to perform his duties as a butcher. He was scheduled for carpal tunnel decompression under local anaesthetic. During exploration, a considerable degree of synovial thickening was evident and a silicone rod was found curled under the median nerve. The rod was removed and a localized flexor synovectomy was performed in addition to a carpal ligament release. Following his carpal tunnel decompression, he was reviewed in the outpatient clinic at two weeks and six weeks postoperatively, and was showing signs of recovery of sensation to the index finger and relief of the paraesthesia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2019-00057 |
| MDR Report Key | 8582921 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2019-05-06 |
| Date of Report | 2019-04-11 |
| Date of Event | 2015-04-01 |
| 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 |