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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CONNECT-SCR-CANN F/PFN+PFNA ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH CONNECT-SCR-CANN F/PFN+PFNA ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 357.029
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 03/28/2018
Event Type  malfunction  
Manufacturer Narrative
Device used for treatment, not diagnosis. Patient id: (b)(6). Patient age not provided for reporting. 510k# unknown: device is not distributed in the united states, but is similar to device marketed in the usa. Original implant date is unknown. (b)(6). Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. Device 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 on an event in (b)(6) as follows: it was reported that the removal of the proximal femoral antirotation nail (pfna) from the connecting screw was not possible. The surgery was delayed about 60 minutes. Devices had to be removed. Surgery was completed with new products. Surgery took four hours. This report is 2 of 2 for (b)(4).
 
Manufacturer Narrative
Additional narrative: concomitant device added. Lot number. Initial reporter facility name and address. Date of manufacture. Dhr review was completed. Part: 357. 029. Lot: 8183899. Manufacturing site: (b)(4). Release to warehouse date: 21. Feb. 2013. The device history record shows this lot of 50 pieces 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. Customer quality conducted an investigation of the returned device. Investigation selection investigation site: cq zuchwil. Selected flow: 2. Device interaction/functional. Visual inspection: the returned pfna nail was tightened with the connecting screw on the insertion handle. No abnormal findings were identified on these returned parts. All in all the parts are in used condition. Function test: the returned assembled pfna nail on the insertion handle could be dissolved without high effort. With the screwdriver (art. 03. 023. 011) could dissolved the connecting screw (art. 357. 029). Summary: the received condition of these parts are concordant with the complaint description and the complaint condition is unconfirmed. With the screwdriver (art. 03. 023. 011) could dissolved the connecting screw (art. 357. 029). No abnormal findings were identified on these returned parts. All in all the parts are in used condition. Based on that and the condition of the parts a product related issue can be excluded. Unfortunately the exact cause which has led to the occurence could not be evaluated. We only can assume that a mechanical overloading situation, for example strongly tighten during assembling the construct, has caused the stuck connection based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected. The design and clinical risk management (dcrm) document was reviewed and found to adequately address the harm of this complaint condition. Corrected data: product code, common device name. 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
Concomitnat device reported: pfna blade (04. 027. 036s, lot l700651, quantity 1).
 
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Brand NameCONNECT-SCR-CANN F/PFN+PFNA
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
MDR Report Key7535209
MDR Text Key108992647
Report Number8030965-2018-53923
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number357.029
Device Lot Number8183899
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

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