MAUDE Adverse Event Report: UNKNOWN ORTHOPEDIC MANUAL SURGICAL INSTRUMENT; PIN, FIXATION, SMOOTH

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

"clinical results of resection arthrodesis by triangular external fixation for posttraumatic arthrosis of the ankle joint in 89 cases".European journal of medical research, 14: 25-29 reported that an ao (the association for the study of internal fixation) fixator was applied with four steinmann nails.The results of this study included two cases requiring further cancellous bone transplant at six and nine weeks for unsatisfactory bony union.There were nine cases of reversible irritation of the dorsal cutaneous nerve.In one case a bony infection around the pin site developed making three surgical procedures for treatment necessary.One patient suffered a fracture of the tibia at the site of the proximal tibial pin site five months after removal of the fixator due to a minor trauma.In four patients a non-union of the ankle arthrodesis developed.In one patients a further procedure was successful, one patient with a previous lisfranc amputation and a difficult soft tissue situation at the amputation site opted for a below knee amputation.In thirty-one cases radiographic signs of arthrosis in the subtalar joint had developed, two patients had a subtalar fusion between index procedure and follow up.Preoperatively only one patient had mild pain, at follow up fifty-four patients had no or only mild pain.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17532775
• MDR Text Key: 321096726
• Report Number: MW5139682
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1