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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: PFNA BLADE ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAIL HEAD ELEMENTS: PFNA BLADE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problems Device-Device Incompatibility (2919); Difficult to Advance (2920)
Patient Problem No Code Available (3191)
Event Date 07/30/2020
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown nail head elements: pfna blade/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Reporter is a synthes employee. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. (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.
 
Event Description
Device report from synthes reports an event in the (b)(6) as follows: it was reported that on (b)(6) 2020, a patient had a very hard bone due to cancer and during the insertion of the blade, the impactor would not fully rotate into its final position. The blade was unable to be locked into place and the impactor could not be removed. The surgeon attempted to hammer the blade into place. The surgeon was unable to advance the blade into its final locking position and the impactor would not release. The surgeon used the hammer to release the impactor. There was a surgical delay of twenty (20) to thirty (30) minutes. Patient outcome was unknown. Concomitant devices reported: impaction instruments: hammer/mallet: trauma (part number unknown, lot unknown, quantity 1), impactor f/pfna blade (part number 03. 010. 410, lot 515379, quantity 1). This report involves one (1) unknown nail head elements: pfna blade. This is report 2 of 2 for (b)(4).
 
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Brand NameUNK - NAIL HEAD ELEMENTS: PFNA BLADE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10393152
MDR Text Key202558460
Report Number8030965-2020-05870
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2020
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: 08/11/2020 Patient Sequence Number: 1
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