MAUDE Adverse Event Report: SYNTHES (USA) IMPACTOR F/PFNA BLADE

Catalog Number 356.823

Device Problem Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information was not provided by reporter.(b)(4).Device is an instrument and is not implanted/explanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.Device is not distributed in the united states, but is similar to device marketed in the usa.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during a surgical procedure to treat a femoral trochanteric fracture on (b)(6) 2016, after the surgeon attached the impactor to the blade, the surgeon could not move the shaft part of the blade.The surgeon decided to use a different sized blade to complete the surgery.There were no adverse consequences reported; however there was a reported surgical delay of unknown duration.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device 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.

• Brand Name: IMPACTOR F/PFNA BLADE
• Type of Device: IMPACTOR
• 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: 5390478
• MDR Text Key: 36821880
• Report Number: 2520274-2016-10449
• Device Sequence Number: 1
• Product Code: HWA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 356.823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1