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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Failure of Implant (1924); Irritation (1941); Pain (1994); Joint Dislocation (2374); Impaired Healing (2378); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Device used for treatment, not diagnosis. Kettler, m. , et al (2007). Flexible intramedullary nailing for stabilization of displaced midshaft clavicle fractures technique and results in 87 patients. Acta orthopadica, 3; 424-429/ this report is for an unknown nail (titanium endomedullary), unknown quantity/unknown lot. Part unknown, udi is unavailable. (b)(6). (b)(4). The investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number were provided. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event Description
This report is being filed after the subsequent review of the following article: kettler, m. , et al (2007). Flexible intramedullary nailing for stabilization of displaced midshaft clavicle fractures technique and results in 87 patients. Acta orthopadica, 3; 424-429. (b)(6). The results of a new minimally invasive procedure based on the use of elastic, stable intramedullary titanium nails were analyzed. From (b)(6) 2001 to (b)(6) 2005, 95 patients with mid shaft fractures were treated by eight different surgeons using elastic titanium nail (synthes, ((b)(4)) or depuy ((b)(4)). The article did not identify which nails were implanted in the patients. The average patient age was 38 years (range 15-74) and included 68 males and 32 females. Of the 95 patients, 8 patients were lost to follow-up no early complications were reported in these patients. Eighty-seven patients were evaluated after an average follow-up period of 13 months (range 6-28). Outcome was assessed using dash score, shoulder function was measured using self-reported constant score. Complications: two (2) patients, the nail missed the medullary canal of the lateral fragment. One (1) patient had a revision to reintroduce the nail; the other refused a further operation and the fracture healed with a slight malunion. One (1) patient had a nonunion after premature implant removal. Two (2) cases the protruding end of the nail at the medial side caused irritation. Three (3) patients healed with angulations of over 30°. Four (4) patients had a dislocation of more than a shaft width. Four (4) patients had hypertrophic callus formation but without neurological symptoms. Two (2) patients complained of pain resulting from load over the fracture. This report is 1 of 3 for (b)(4). This report is for unknown nail (titanium endomedullary), unknown quantity and lot number.
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Manufacturer (Section D)
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
MDR Report Key5605300
MDR Text Key43538200
Report Number2520274-2016-12175
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Other Device ID NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2016
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?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/25/2016 Patient Sequence Number: 1