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Catalog Number 357.371
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/24/2016
Event Type  malfunction  
Manufacturer Narrative
Patient height reported as 5 feet 4 inches. Device is an instrument and is not implanted/explanted. (b)(4). The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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 that an initial trochanteric fixation nail (tfn) procedure for the left femur took place on (b)(6) 2016 where several device malfunctions occurred. The helical blade coupling screw broke into two pieces while being hammered by an unknown mallet. Those pieces were retrieved with difficulty and unspecified additional intervention resulting in a thirty (30) minute surgical delay. Additionally, as the helical blade inserter was removed it was noted the tip was broken in pieces as a result from the hammering. All pieces were retrieved from the broken inserter. It was also determined the threads of the blade guide sleeve became damaged while the surgeon was trying to remove the helical blade inserter. The buttress compression nut for the blade guide sleeve could no longer be turned, and was no longer usable because of the damage to the threads. This pushed the blade guide sleeve into the 130 degree aiming arm. The buttress compression nut and the blade guide sleeve became stuck together. During the implantation of the helical blade and the nail the surgeon reported difficulty in implanting the two devices. A pair of non-synthes pliers was used to remove the helical blade. The surface of the helical blade was scratched while it was being removed. The helical blade was connected to both the helical blade inserter and the inserter coupling screw; these became stuck together for a short time but were later separated. The helical blade and the nail were both removed and replaced with two new back-up implants of the same kind to complete the procedure. Additional devices were also damaged during the procedure: tfn aiming arm and connecting screw were bent by the mallet. The surgeon had concerns the connecting screw might be bent and could not be tightened correctly. The 130 degree aiming arm, guide wire, and 4mm trocar were most likely bent or damaged as well. The procedure was completed successfully. Concomitant devices reported were: non-synthes pliers (part/lot unknown, quantity 1); mallet, (part/lot unknown, quantity 1); tfn nail (part 456. 357s, lot unknown, quantity 1). This is report 4 of 10 for (b)(4).
Manufacturer Narrative
(b)(4). 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
A device history record review was performed on the part: 357. 371, lot: 4779621: manufacturing location: synthes (b)(4), release to warehouse: 13-aug-2004. Review of device history records showed that there were no issues during the manufacture of this product that would contribute to this complaint condition. A product development investigation was performed. Multiple malfunctions were reported during a trochanteric fixation nail (tfn) procedure. The instruments are routinely used in the titanium trochanteric fixation nail system. Of those reported, the following were able to be confirmed. Coupling screw ¿ 357. 377, lot 5359636, mfg 30-jan-2007 ¿ broken cap ¿ 30 minute delay - confirmed. Blade guide sleeve ¿ 357. 369, lot 4474601, mfg 22-apr-2003 ¿ stuck - confirmed. Buttress compression nut - 357. 371, lot 4779621, mfg 13-aug-2004¿ stuck ¿ confirmed. Helical blade inserter - 357. 372, lot 4576929, mfg 10-apr-2003 ¿ broken tip ¿ confirmed. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. A visual inspection, device history record (dhr) review, manufacturing investigation, service history review, and drawing review were performed as part of this investigation. The following devices were examined and were determined to be unconfirmed. All of the instruments displayed significant wear and impact marks but the surface damage would not impact the functionality of the complaint. The helical blade was not returned therefore the damage could not be confirmed. As the complaints against these devices are unconfirmed, a detailed complaint investigation including a complaint history review and risk document review is not required. 130 deg aiming arm - part 357. 366, lot 4733180, mfg 04-mar-2004 ¿ bent ¿ unconfirmed. Insertion handle ¿ 357. 411, lot 4481673, mfg 20-dec-2002 ¿ bent ¿ unconfirmed. Connecting screw ¿ 357. 397, lot 6921363, mfg 26-june-2012 ¿ bent ¿ unconfirmed. Wire guide - 357. 381, lot 4825180, 20-oct-2004 ¿ bent ¿ unconfirmed. Trocar ¿ 357. 383, lot 4464407, mfg 02-oct-2002 ¿ bent ¿ unconfirmed. Helical blade ¿ 465. 304 ¿ nick/gouged/chipped ¿ unconfirmed (was not returned). Blade guide sleeve(part # 357. 369) and buttress compression nut (357. 371) were returned and reported to have become stuck together. This condition is confirmed; the buttress/compression is jammed near the proximal end of the sleeve, obscuring the part number. The nut is entirely immobile and will not move even when applying a moderate amount of force. The threads of the guide sleeve distal to the buttress compression nut as well as the distal side of the nut displayed several impact marks. Relevant drawings were examined. The design, materials and finishing processes were found to be appropriate for the intended use of these devices. It is likely that several years of use and possible rough handling during surgery or sterile processing has led to deformed threads causing this complaint condition. 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.
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Manufacturer (Section D)
1303 goshen parkway
west chester PA 19380
Manufacturer (Section G)
1303 goshen parkway
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
MDR Report Key6254167
MDR Text Key65073741
Report Number2530088-2017-10013
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number357.371
Device Lot Number4779621
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/16/2017 Patient Sequence Number: 1