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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH 10MM/130 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY

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OBERDORF : SYNTHES PRODUKTIONS GMBH 10MM/130 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.042S
Device Problem Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/14/2017
Event Type  malfunction  
Manufacturer Narrative
Device history records review was completed for part# 04. 037. 042s, lot# 9925489. Manufacturing location: (b)(4), manufacturing date: oct 23, 2015, expiry date: oct 31, 2025. Part #: 04. 037. 042s, lot#: 9925489 (sterile) - 10mm/130 deg ti cann tfna 170mm - sterile. Quantity 6. Component parts reviewed: part 04. 037. 942. 2 - lock prong, 130 degree, tfna bp-55 lot - 9432263, part 04. 037. 912. 4 - wave spring, shim ended bp-55 lot - 7840803, part 04. 037. 912. 3 - tfna lock drive bp-58 lot - 9893722, part 21127 - raw material lot bp-80 lot - 9909051. Raw material received from supplier (b)(4). Certified test report received from (b)(4) for titanium and certificate of analysis received from (b)(4). Meet specification. Raw material receiving/putaway checklist meet requirements. Inspection sheet for in-process/inspect dimensional/final and inspection sheet for tfna assembly inspection met inspection acceptance criteria. No non-conformance reports were generated during production. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Complaint is confirmed as complaint description could be confirmed based on the received pictures/x-rays. 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 not available for reporting. Explant of device was not reported. Complainant part is not expected to be returned for manufacturer review/investigation. 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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported patient was implanted with the trochanteric femoral nail-advanced (tfna) on (b)(6) 2017 for a right femoral trochanteric fracture. Surgery was completed with a delay of approximately 15 minutes and no adverse consequence to patient. It is not known what caused the delay. Postoperative x-ray confirmed the shade of a protruding object. Surgeon noted the protruding object may be a bent portion of the short nail implanted, which may have been created by the excessive force used to detach the instrument from the short nail. (b)(4).
 
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Brand Name10MM/130 DEG TI CANN TFNA 170MM - STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF : SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
MDR Report Key7181005
MDR Text Key280783139
Report Number8030965-2018-50253
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.042S
Device Lot Number9925489
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2018
Is This a Reprocessed and Reused Single-Use Device? No

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