MAUDE Adverse Event Report: SYNTHES USA; BOLT, NUT, WASHER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Sargeant, et al.(1994).The ao unreamed tibial nail: a 14-month follow-up of the 1992 tt experience.Injury: international journal of the care of the injured (1994) vol.25, no.7, 423-425.This report is for unknown bolt, unknown quantity, unknown lot.(b)(4) revision surgery metalwork exchange in two cases, metalwork exchange and bone graft in one case, and metalwork removal in one case, and non-union; (b)(4) implant failure.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article received.This report is being filed after the subsequent review of the following literature article: sargeant, et al.(1994).The ao unreamed tibial nail: a 14-month follow-up of the 1992 tt experience.Injury: international journal of the care of the injured (1994) vol.25, no.7, 423-425.Thirteen tibial nails were inserted in 13 patients.One patient was female.The average patient age was 27 years and 10 months (range 18-46 years).Eleven patients were injured in high-speed motorbike accidents, one was injured playing hockey and one sustained a low-energy fall.The patients were treated with the ao unreamed tibial nail.There were two equipment complications associated with insertion and one early compartment syndrome.Two patients needed a split skin graft and one other patient required hyperbaric oxygen therapy with a split skin graft to bring about impact wound closure.At 14 months, two nails had been electively removed.There were four cases of locking bolt failure leading to metalwork exchange in two cases, metalwork exchange and bone graft in one case and nail removal in one case.Two patients had undergone bone graft with nail removal or exchange.Four patients had not achieved bony union.This is report 3 of 3 for (b)(4).This report is for unknown locking bolts that fractured postoperatively and refers to the following serious injuries--metalwork exchange in two cases, metalwork exchange and bone graft in one case, and metalwork removal in one case, and non-union.

• Type of Device: BOLT, NUT, WASHER
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5418388
• MDR Text Key: 37713244
• Report Number: 2520274-2016-10895
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention