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

Catalog Number 03.010.410

Device Problems Break (1069); Material Fragmentation (1261); Fitting Problem (2183); Device Operates Differently Than Expected (2913)

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

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Device is not distributed in the united states, but is similar to a device marketed in the us.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a patient presented with a large metastatic tumor in the proximal femur that required prophylactic nailing.The surgeon chose to implant a proximal femoral nail antirotation (pfna) construct.Upon encountering extremely hard bone, which was described as rock/marble-like, the following events happened: the drill bit used to open the femur was used under power; still, extreme force was needed to make any progress.The surgeon described the drill as burning through the hard bone rather than cutting it.The drill bit wound up breaking in the area of connection with the jacobs drill attachment.The impactor broke at the hex tip as the surgeon attempted to use it to assist with nail insertion.The tip of the impactor was placed into the recess of the connecting screw in an effort to implant the nail.The nail was eventually inserted by over-reaming the shaft.Examination of the connecting screw showed evidence of instrument pieces in the recess.A second impactor experienced fitting problems during the procedure.Upon measuring for appropriate blade length, the reamer could only advance to 85mm due to the bone density.As a result, an 80mm blade was selected for insertion, but the blade handle could not be turned after insertion in order to lock it in place.The blade's tip was checked and found to be freely rotating.Eventually, the impactor became disengaged from the blade after the application of excessive forces.The aiming arm broke as it was in situ to insert the nail.It was noted that the arm came loose several times and eventually one (1) of the locating lugs came entirely loose.Due to these intra-operative events, the surgery was prolonged by more than thirty (30) minutes.The procedure was ultimately continued and completed with devices from an alternative set.Concomitant device(s) reported: pfna nail (part/lot: unknown, quantity: 1).This report is 4 of 4 for (b)(4).

Manufacturer Narrative

(b)(4).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.

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.

Event Description

It was reported the procedure was successfully completed.But the pfna blade was shorter than would have been normally expected.

Manufacturer Narrative

Product investigation summary: the evaluation of the connecting screw (part: 357.029) has shown that a front piece of a blade impactor (most likely the reported part 03.010.410) is completely stuck in the hexagon of the recess.Additionally, there are strong tool marks visible on the front piece of the impactor, which most likely caused the issue with the connecting screw since the piece preventing accessibility of the hexagon.According to the complaint description, the impactor was used to insert the nail due to the very hard bone.This is considered a misuse because the impactor is designed to impact blades not nails.This misuse finally led to the loosening of the impactor front piece as it was not designed to withstand such forces.Overall conclusion: no product related issues could be detected.Based on the provided information, it is most probable that extremely hard bone, which was described as rock/marble-like, required the use of excessive force, which finally led to a mechanical overload situation of the instruments.No product related issue could be detected.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Update: a visual inspection of the returned products was conducted on (b)(6) 2016.It was then detected that the second impactor (part 03.010.410) was also broken and a piece of it remained stuck in the recess of the connecting screw.

• Brand Name: IMPACTOR F/PFNA BLADE
• Type of Device: IMPACTOR
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5730045
• MDR Text Key: 47549686
• Report Number: 2520274-2016-13194
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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