MAUDE Adverse Event Report: SYNTHES ELMIRA TFNA SCREW 90MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.038.090S

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 07/20/2016

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.(b)(4).Device broke intra-operatively and was not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).(b)(4).Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing location: (b)(4) - manufacturing date: november 13, 2015 - expiry date: november 1, 2025.A review of the device history record revealed no complaint related anomalies.The device history record (including that of the raw material) shows this lot was processed through the normal manufacturing and inspection operations with no rework or non-conformities noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented that would contribute to this complaint condition.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 underwent a surgical procedure on (b)(6) 2016 in order to treat an intertrochanteric femoral fracture.After the surgeon inserted a femoral neck screw, the inserter was turned 180-degrees in the opposite direction in order to check the locking rotation of the femoral neck screw within the set screw.The surgeon noted that the inserter rotated without any load; it was then noted that the femoral neck screw had not locked with the set screw.The surgeon made another attempt at tightening, but the screw would not lock.The surgeon removed the screw and the nail and noted that the shaft of the femoral neck screw had broken.The fragmented portion did not fall into the patient and it was subsequently located post-operative.Intra-operative images were captured anyway in order to ensure that there were no retained fragments.The surgeon then opted to insert a new nail and screw of a different size.The newly inserted implants successfully locked and the procedure was completed.Due to the intra-operative events, a forty (40) minute surgical prolongation was noted.Concomitant device(s) reported: tfna nail (part: 04.037.042s / lot: 9938417 / quantity: 1) and screwdriver (part/lot numbers: unknown / quantity: 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.The devices associated with this complaint have been re-assessed.At this time, only the screwdriver is being considered concomitant.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

Concomitant device(s) reported: screwdriver (part/lot: unknown / quantity: 1).This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (tfna titanium lag screw, part number 04.038.090s, lot number 927733).The subject device was received with the complaint reporting that the saddle of the set screw broke intraoperatively.This resulted in a 40 minute surgical delay.The fragment was able to be located and retrieved.The 04.038.090 lag screw was returned in good condition with no observable signs of damage.The malfunctioning screw identified in the complaint description refers to the set screw and not the lag screw.As such, further investigation would not be performed on the lag screw as the complaint against it is unconfirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TFNA SCREW 90MM - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5850494
• MDR Text Key: 51268905
• Report Number: 3003506883-2016-10134
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• 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,Followup
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.090S
• Device Lot Number: 9927733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention