• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH CANNULATED CONNECTING SCREW ROD, FIXATION, INTRAMEDULLARY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OBERDORF : SYNTHES PRODUKTIONS GMBH CANNULATED CONNECTING SCREW ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 03.037.010
Device Problem Mechanical Jam (2983)
Patient Problem No Code Available (3191)
Event Date 12/06/2017
Event Type  malfunction  
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.
 
Event Description
Concomitant devices: part 03-010-496, lot t125557, qty 1, part 03-010-517, lot 9642306, qty 1, part 03-037-011,lot 9258580, qty 1, part 03-037-028, lot 9701330, qty 1, part 03-037-029,lot 9320929, qty 1, part 03-037-114, lot 9600689, qty 1, part 03-140-023, lot 2626, qty 1.
 
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.
 
Event Description
Concomitant devices reported: hybrid insertion handle (part# 03. 037. 011, lot# 9258580, quantity 1). T-handle cann w/quick-coupl hex12 (part# 03. 010. 496, lot# t125557, quantity 1). Scrdriver-hex ø8 w/t-handle w/spheric-he (part# 03. 010. 517, lot# 9642306, quantity 1). Scrdriver-hex 5 flex cann (part# 03. 037. 028, lot# 9701330, quantity 1). Scrdrivershaft-hex 5 w/hex-coupl 6 f/sta (part# 03. 037. 029, lot# 9320829, quantity 1). Aim-arm 125° f/stat+dyn dist lock (part# 03. 037. 114, lot# 9600689, quantity 1). Torque limiter 6nm f/ao/asif f/reamer (part# 03. 140. 023, lot# 2626, quantity 1).
 
Manufacturer Narrative
Additional narrative: a device history record (dhr) review was performed for part number: 03. 037. 010, synthes lot number: 9667929: release to warehouse date: 16. Nov. 2015: manufacturing site, (b)(4): no non-conformance reports (ncrs) were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. A product investigation was performed. The nail was able to be assembled appropriately with the returned connecting screw and insertion handle. The connecting screw was able to be disconnected from the nail without issue. The complaint was not confirmed, and was unable to be replicated. The connecting screw has a small piece of the thread chipped out; however, it did not impact the functionality of the device. Relevant drawings were reviewed. No design issues or discrepancies were identified during investigation. Dimensional inspection of the connecting screw is not applicable, as the issue was unable to be replicated with the returned devices. No definitive root cause could be determined; however, based on the complaint description it is likely that biological matter interfered with disconnecting of the devices. The surgeon was able to separate the devices after lightly hammering the circumference of the connected area. There were no issues during the manufacture of this product that would contribute to this complaint condition. During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. 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
Patient information is unknown. It is unknown when the event occurred. This report is for a connecting screw/unknown lot. Device is an instrument and is not implanted/explanted. Complainant part has been received, however, product investigation is not yet completed; no conclusion could be drawn. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 the reported devices were used in surgery for femoral trochanteric fracture on (b)(6) 2017. After inserting the nail and a blade into a proper place, the surgeon fixed a set screw (originally came together with the nail) with a flexible driver and a torque driver. Then, the surgeon backed the driver off by turning counterclockwise 90 degrees. However, the nail in question was come up. As the nail was come up, the surgeon tried to replace it with another nail. However, the surgeon was not able to disconnect the nail and a connecting screw which were assembled by an insertion handle. Because some countermeasures failed, the surgeon lightly hammered the circumference of the connected area. Finally, the nail was detached and was exchanged with the replacing nail. The surgery was delayed by 30 minutes. There was no adverse consequence to the patient. The surgeon commented that he performed the surgery as per ifu. After the surgery, the sales rep confirmed that the same incident could not be replicated with the nail in question. However, the set screw¿s movements were not smooth. Concomitant devices: 1x 03. 037. 011 / lot unk (insert-handle hybrid). This complaint involves 3 parts.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCANNULATED CONNECTING SCREW
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF : SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf
SZ
MDR Report Key7164106
MDR Text Key261889087
Report Number8030965-2018-50062
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 12/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.010
Device Lot Number9667929
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2018
Is This a Reprocessed and Reused Single-Use Device? No

-
-