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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI END CAP FOR TFNA 0MM EXTN - STERILE ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH TI END CAP FOR TFNA 0MM EXTN - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.000S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2018
Event Type  malfunction  
Manufacturer Narrative
Initial reporter is synthes sales representative. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. A review of the device history records has been requested. 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) 2018, an osteosynthesis surgery for the femoral trochanteric fracture was performed with a proximal femoral nailing advanced system (tfna). During the procedure, the end cap could not be inserted into an unknown tfna nail. The surgery was completed successfully by using another unknown end cap. There was no adverse consequence reported. The surgery was delayed by less than 30 minutes. Concomitant devices reported: unknown nail (part# unknown, lot# unknown, quantity 1); unknown locking screw (part# unknown, lot# unknown, quantity 1) and unknown helical balde (part# unknown, lot# unknown, quantity 1). This report is for one (1) ti end cap for tfna 0mm extn - sterile. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Part: 04. 038. 000s; lot: 1l11370; manufacturing site: (b)(4) release to warehouse date: august 30, 2018; expiry date: august 01, 2028 the device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted. This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process. Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition. Summary of the manufacturing investigation: the received condition of the complaint does not agree with the complaint description since the endcap has passed through the go/no go gages -inspects the feature m11x1 ¿ 6g- which simulates the thread of the tfna nail. In addition, this complaint is rated as not confirmed since there is no evidence to support the allegation made in the complaint. Since no deviations were found in the documentation as well as during this investigation, all relevant measurements performed are according to the specifications, which indicates that there is no manufacturing issue, no further actions have been taken. 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.
 
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Brand NameTI END CAP FOR TFNA 0MM EXTN - STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8206268
MDR Text Key131716960
Report Number8030965-2018-59324
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.000S
Device Lot Number1L11370
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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