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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL INSERTION HANDLES ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH UNK - NAIL INSERTION HANDLES ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/21/2021
Event Type  malfunction  
Manufacturer Narrative
This report is for an unknown nail insertion handle/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. 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. 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 the patient underwent the open reduction internal fixation surgery for surgical neck of proximal humerus fracture. When the surgeon inserted the nail, the nail was inserted slightly laterally, but it was within the allowable range, so the bone was dug using a crown reamer. It was reamed about one third of the normal length. Because the bone metastasis was severe, the surgeon used a reaming rod but had difficulty inserting the nail distally. The part of the bone that had not been reamed sufficiently blocked and the nail could not be inserted until the end, so the bone was again reamed through the reaming rod. However, the reamer rotated eccentrically to the outside and the hole became too large. The surgeon tried to insert the nail as inward as possible, but the nail moved outward. After repeated attempts, the hole was connected to the fracture line of the greater tuberosity. The surgeon gave up the nail fixation and decided to arrange the philos plate urgently. This arrangement took 150 minutes. The surgery was completed successfully with 150 minutes delay. After surgery, the surgeon commented that the second reaming should have followed the surgical technique. No further information is available. This report is for one (1) unknown nail insertion handles. This is report 2 of 3 for (b)(4).
 
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Brand NameUNK - NAIL INSERTION HANDLES
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12488225
MDR Text Key271909602
Report Number8030965-2021-07835
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2021
Is this an Adverse Event Report? No
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 Received08/21/2021
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? No
Type of Device Usage Unkown

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