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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES SALZBURG 4.9MM TI LOCKING BOLT 36MM ROD,FIXATION,INTRAMEDULLARY

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SYNTHES SALZBURG 4.9MM TI LOCKING BOLT 36MM ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 459.360VS
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2017
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. (b)(4). A device history record review was performed for the subject device lot number 5941483. Manufacturing location: (b)(4). Date of manufacture: 18. Jan. 2017. Expiration date: 01. Jan. 2027. The review showed that there were no issues during the manufacture or sterilization of the product that would contribute to this complaint condition. No non-conformances were generated during the production or sterilization of the subject device. Dial cannot be unchecked as it was inadvertently checked. Date of product return was reported on (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product development investigation was completed. Visual inspection shows that the in-hex recess is completely worn out. The recess is rounded and therefore it was not possible to connect the screwdriver as foreseen and to remove the locking bolt accordingly. Due to the damage, measuring of the in-hex part was not possible. However, the visible signs clearly indicate excessive applied torsional force while removal procedure as root cause for the damage. No product related problem could be identified. This complaint is confirmed. (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
Additional product codes: hty, jdw, jds, jdn. Device malfunctioned intra-operatively and was not implanted / explanted. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(6). A review of the device history records has been requested. 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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported patient underwent a procedure for a distal femoral fracture on (b)(6) 2017. The distal femoral nail (dfn) was fixed by the locking bolts. Surgeon attempted to remove one of the locking bolts with the hexagonal screwdriver but the tip of the screwdriver slipped out of the head of the locking bolt. Surgeon was able to remove one of the locking bolts utilizing round-nosed pliers. This locking bolt was replaced with another locking bolt that was 2mm shorter in length. The other locking bolt was completely stripped and could not be removed, preventing surgeon from inserting anything into that plate hole. It was reported there was potentially a third locking bolt that was also difficult to remove. Procedure was delayed approximately 20 minutes. Concomitant devices reported: distal femoral nail (part number unknown, lot number unknown, quantity 1), plate (part number unknown, lot number unknown, quantity 1), screwdriver (314. 750, lot 5000213, quantity 1), removal tool (part number unknown, lot number unknown, quantity 1). This report is for one (1) locking bolt. This is report 2 of 3 for (b)(4).
 
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.
 
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Brand Name4.9MM TI LOCKING BOLT 36MM
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES SALZBURG
karolingerstrasse
salzburg 5020
AU 5020
Manufacturer (Section G)
SYNTHES SALZBURG
karolingerstrasse
salzburg 5020
AU 5020
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6617752
MDR Text Key126159056
Report Number3009417901-2017-10017
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819702530
UDI-Public(01)07611819702530(10)5941483
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K970733
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number459.360VS
Device Lot Number5941483
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/07/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/07/2017 Patient Sequence Number: 1
Treatment
PLATE (PART AND LOT UNKNOWN, QTY 1); REMOVAL TOOL (PART AND LOT UNKNOWN, QTY 1); SCREWDRIVER (314.750, LOT 5000213, QTY 1)
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