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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: EXPERT TIBIAL NAIL

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: EXPERT TIBIAL NAIL Back to Search Results
Catalog Number UNK - CONSTRUCTS: EXPERT TIBIA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Skin Irritation (2076); Impaired Healing (2378); No Code Available (3191)
Event Date 01/29/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Pma/510k: this report is for an unknown - constructs: expert tibial nail/unknown lot number. Without the specific part number, the udi number and 510k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. Investigation summary 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. 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. (b)(4).
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: hessmann, m. H. Et al. (2020), suprapatellar nailing of fractures of the tibia, operative orthopädie und traumatologie, vol. Xx, ages 1-15 ((b)(6)). The objective of this study is to present intramedullary nailing of tibia fractures via a suprapatellar, transarticular approach with the knee joint in 20¿30 degrees of flexion and the use of specific protection tubes to preserve intra-articular structures. Between 2013 and 2015, 17 patients (15 males and 2 females) with an age range between 18 and 67 years (average 32 years) were treated with an expert tibia nail (etn, depuy synthes, (b)(6) usa). Follow-up was between 3 months and 2 years. The following complications were reported as follows: 1 patient's fracture did not heal; therefore, an exchange nail surgery was carried out through a conventional transpatellar tendon approach. 3 patients with open fractures needed skin grafting for definitive wound closure. 2 patients complained about anterior knee pain and one patient of a tenderness over the surgical scar at the point of entry. This is for an expert tibia nail (etn, depuy synthes, (b)(6) usa). This report is for one (1) unk - constructs: expert tibial nail. This report is 1 of 1 for (b)(4). A copy of the literature article is being submitted with this medwatch.
 
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Brand NameUNK - CONSTRUCTS: EXPERT TIBIAL NAIL
Type of DeviceUNK - CONSTRUCTS: EXPERT TIBIAL NAIL
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 Key9891914
MDR Text Key194921098
Report Number8030965-2020-02375
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK - CONSTRUCTS: EXPERT TIBIA
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 Received03/30/2020
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: 03/27/2020 Patient Sequence Number: 1
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