MAUDE Adverse Event Report: SYNTHES USA; EXTRACTOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Unknown when non-union occurred.This report is for unknown- plate/unknown lot number.Not explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review could not be conducted due the insufficient information¿s.No further investigation possible as there was no product returned.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Report from synthes (b)($) reports an event in (b)(6) as follows: it was reported that a procedure: exchange of pfna was conducted.In (b)(6) 2013, a pfna was inserted for a proximal femoral fracture.The fracture was a long spiral and therefore circulate wires were also placed around the proximal femur.The patient failed to unite resulting in a non-union.The nail in place broke after approximately 2.5 years.Product specialist discussed this case with the surgeon at length and he was of the opinion that the failure was due to the non-union rather than an issue with the nail and the nail actually proved to be quite durable given that it lasted so long before breakage.The product is a pfna 125 degrees, 12 diameter 380 length.The nail was removed using the synthes nail removal set.It was replaced with an afn 14mm diameter by 400mm.This report is 3 of 4 for (b)(4).

Manufacturer Narrative

Implant date: original implant took place sometime in (b)(6) 2013.Implant and explant dates: were transposed in initial mw; explant date is (b)(6) 2015.Device was used for treatment, not diagnosis if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: EXTRACTOR
• 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: 5192830
• MDR Text Key: 30010569
• Report Number: 2520274-2015-16954
• Device Sequence Number: 1
• Product Code: HWB
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2015

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2015
• Initial Date FDA Received: 10/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/10/2015; 11/10/2015
• 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?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention