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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 8MM TI MULTILOC PROX HUMERAL NAIL/LEFT/CANN/160MM-STER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH 8MM TI MULTILOC PROX HUMERAL NAIL/LEFT/CANN/160MM-STER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.016.035S
Device Problems Device-Device Incompatibility (2919); Difficult to Advance (2920)
Patient Problem Bone Fracture(s) (1870)
Event Date 04/30/2021
Event Type  Injury  
Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j employee. If additional information is made available, the investigation will be updated as applicable. 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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation (orif) surgery for the proximal humeral fracture with the instruments and nail in question. The surgeon checked the nail size to be used before surgery. The surgeon was planning to use a 9. 5 mm nail, but in the preoperative image, the medullary cavity was unexpectedly small, so he used an 8. 0 mm nail. The intramedullary nail was inserted through the guide rod, but the medullary cavity was too narrow to get inside. The surgeon used a hammer because the nail could not be inserted (sales advised against it. The hospital did not have a reamer). The nail could be inserted up to the specified position. The surgeon inserted three proximal screws and moved on to insert the distal screws, but the drill bit interfered with the nail, and it did not go in, so the surgeon removed the drill bit, tap it with a hammer, let it go through the intramedullary nail, re-attach it to the drill bit, and drill to the opposite side. After measuring, a screw was inserted. Because the drill bit interfered on the proximal side as well, the same procedure was used for penetration, measurement, and insertion. After insertion of the distal screws, the surgeon checked with images to see if it was in, but it was difficult to see, so the surgeon once took off the insertion handle and internally and externally rotated the patient arm, and the surgeon found out that the distal screws were dislodged from the intramedullary nail. The dislodged screws were removed, and the removed insertion handle was reattached. A pre-drill was performed using a set of sleeves and a 2. 4 mm k-wire to be used as a lateral stop, and a 3. 0 mm re-pre-drill was performed on the drilled hole. Finally, a 3. 2 mm drill was performed to insert the screws. Both proximal and distal screws were inserted using the same method. The endcap was inserted last and closed the incision after confirmation. A final check was performed on the postoperative x-ray to confirm that there was no deviation of the screw, but it was found that the outer bone was partially split at the distal end of the nail. The surgery was completed within thirty (30) minutes surgical delay. The surgeon commented that soft tissue was thick, and the sleeve was not firmly extended until it came in contact with the bone (skin incision was too small). No further information is available. This report is for one (1) 8mm ti multiloc prox humeral nail/left/cann/160mm-ster. This is report 11 of 20 for complaint (b)(4).
 
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Brand Name8MM TI MULTILOC PROX HUMERAL NAIL/LEFT/CANN/160MM-STER
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key11895191
MDR Text Key252978680
Report Number8030965-2021-04376
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.016.035S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/27/2021 Patient Sequence Number: 1
Treatment
AIM-ARM ANT F/MULTILOC HUM NAIL SYST; AIM-ARM LAT F/MULTILOC PHN; CONNECSCR CANN F/ML HUM NAIL; CONSCR F/ML HUM NAIL SYST; CONSCR F/ML HUM NAIL SYST; DRILL BIT Ø3.2 CALIBR L145 3FLUTE; DRILL BIT Ø3.2 CALIBR L145 3FLUTE; DRILL BIT Ø3.2 CALIBR L145 3FLUTE; DRILLSL 8/3.2 F/03.010.063; DRILLSL 8/3.2 F/03.010.063; INSERT-HANDLE F/ML HUM NAIL; LOCKSCR Ø4 L24 F/NAILS TAN DBLUE; LOCKSCR Ø4 L24 F/NAILS TAN DBLUE; LOCKSCR Ø4 L24 F/NAILS TAN DBLUE; PROTECT SLEEVE 12/8 L188; PROTECT SLEEVE 12/8 L188; TROCAR Ø3.2 F/03.010.064; TROCAR Ø3.2 F/03.010.064; TROCAR Ø3.2 F/03.010.064; UNK - DRILL; UNK -HAMMER/MALLET
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