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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH END-CAP F/A2FN CANN EXTENS. 5 TAN GREY ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH END-CAP F/A2FN CANN EXTENS. 5 TAN GREY ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.009.001S
Device Problems Failure To Adhere Or Bond (1031); Fitting Problem (2183)
Patient Problem No Code Available (3191)
Event Date 12/08/2017
Event Type  Injury  
Manufacturer Narrative
Dhr review was completed. Part number: 04. 009. 001s, synthes lot number: l518055, release to warehouse date: 17. Aug. 2017, expiry date: 01. Aug. 2027, manufacturing site: (b)(4). No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Customer quality conducted an investigation of the returned device. Part was sent to manufacturing site for investigation. As received condition of device: the part (lot l518055) has been returned not in original packaging. There are not visible damages on the surface. Information etched on product matches to complaint system and dhr. Dhr review: lot l518055 was manufactured in august 2017 in (b)(4). All the inspections performed according to inspection sheet passed. No ncrs were generated. Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Lot l518055 was manufactured starting from raw material lot l501689. The certificate of the raw material lot l501689 has been reviewed. In the relative certificate, it is reported that the material is conforming. Product inspection: the part (lot l518055) was inspected for all the features pertinent to the complaint condition according to the product investigation matrix ¿does not fit with other parts¿ reported in the procedure (b)(4). All the measurable features pertinent to complaint condition have been found conforming to specification. The thread m8 x 0. 76-6g is visually damaged post production for this reason is not measurable. No evidence of nonconformance manufacturing related. The raw material has been verified through review of certificate documented in the dhr review section. Conclusion: considering that all relevant measurable product features meet specification and no visual defects manufacturing related have been identified on returned items, the conclusion of the product investigation is that the returned part is conforming from a manufacturing perspective. Disposition: the manufacturing investigation is disposed as confirmed due the fact that the thread is visually damaged. The manufacturing investigation is considered not valid for (b)(4) because there is no evidence of issues manufacturing related and only the end cap item was returned and it was found conforming to specification. The coupling with the nail could not be verified due to the fact that the nail was not returned. No manufacturing related issue was identified, dcrm investigation shows that the complaint is adequately addressed by the risk assessment. 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.
 
Manufacturer Narrative
Patient¿s identifier, date of birth and weight are unknown. Due to the intra-operative events, the device was not successfully implanted. As such, implant/explant dates are not applicable. Pma / (510k): device is not distributed in the united states, but is similar to device marketed in the usa. To capture the surgical intervention: the incision was enlarged and unknown bone wax was applied to the nail instead of an end cap, and the surgery was completed with a 30-minute delay. The subject device has been received and the product evaluation is in progress. No conclusion can be drawn. 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 that a surgery for femoral diaphyseal fracture was performed on (b)(6) 2017. After the nail and some screws were inserted, the surgeon could not fix the end cap 10mm to the nail. In addition to the main surgeon, three other surgeons took turns to correct this difficulty with the following countermeasures, which did not succeed: 1. Repositioning of the patient¿s body, 2. Enlarging the incision area, 3. Lightly hitting to the driver for inserting end cap with a hammer, 4. Replacing with end cap 5mm and end cap 0mm. Finally, unknown bone wax was applied to the nail instead of an end cap, and the surgery was completed with a 30-minute delay. There was no adverse consequence to the teenage patient. The surgeon commented that hammering might have damaged threads of the nail. Procedure was completed successfully. Concomitant device reported: unknown hammer/mallet (part # unknown, lot # unknown, quantity 1). This report is for one (1) end-cap f/a2fn cann extens. 5 tan grey. This is report 2 of 4 for complaint (b)(4).
 
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Brand NameEND-CAP F/A2FN CANN EXTENS. 5 TAN GREY
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7165884
MDR Text Key270776708
Report Number8030965-2018-50085
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.009.001S
Device Lot NumberL518055
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/04/2018 Patient Sequence Number: 1
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