MAUDE Adverse Event Report: SYNTHES SALZBURG 4.9MM TI LOCKING BOLT 36MM; PIN, FIXATION, SMOOTH

Catalog Number 459.360VS

Device Problems Difficult to Insert (1316); Fitting Problem (2183)

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

Event Date 07/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Due to the reported intra-operative event, the device 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).Investigation could not be completed and no conclusion could be drawn as no device was returned.A review of the device history records has been requested and is currently pending completion.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 a sustained intertrochanteric femoral fracture.During the procedure, the drill bit reportedly interfered with the nail.The drill bit reportedly went through the cortical bone on the opposite side.As a result, the locking bolt also interfered with the nail and could not be successfully placed through the hole.The surgeon abandoned insertion attempts with the locking bolt and completed the procedure.There was no reported surgical delay or additional medical intervention.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A device history record review was performed for the complaint device lot.Manufacturing location: (b)(6).Manufacturing date: sep 8, 2015.Expiration date: aug 1, 2025.The (b)(4) piece lot was sterilized by supplier, (b)(6).The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the complaint device.The complaint device is currently in the evaluation process.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.A manufacturing investigation was performed for the subject device (4.9mm ti locking bolt 36mm, part number 459.360vs, lot number 5935878).The device was received with visual deformation of the inner hexagon.The subject device was re-inspected for all the features pertinent to complaint condition statement, ¿then the surgeon tried to insert the locking bolt; but it interfered to the nail and didn¿t go through the hole." the inspection (visual) of the inner hexagon shows a deformation caused by the surgeon.As previously reported, a device history record review was performed for the complaint device lot.Manufacturing location: (b)(4).Manufacturing date: sep 8, 2015.Expiration date: aug 1, 2025.The (b)(4) piece lot was sterilized by supplier, (b)(4).The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the complaint device.The complaint condition is unconfirmed from a manufacturing perspective.The root cause is attributed to either the device being worn from normal use and servicing but more likely is attributed to the use of the instrument as described by the surgeon and the resulting damage caused by contact of the locking bolt with the nail and possible slippage of the screwdriver.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.9MM TI LOCKING BOLT 36MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer (Section G): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5806404
• MDR Text Key: 49947991
• Report Number: 3009417901-2016-10024
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970733
• 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: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 459.360VS
• Device Lot Number: 5935878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1