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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA Ø10 LONG R 130° L340 SST ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA Ø10 LONG R 130° L340 SST ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 272.280S
Device Problem Break (1069)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative
Patient height reported as 160. 0 cms. Complainant part is not expected to be returned for manufacturer review/investigation. Device is not distributed in the united states, but is similar to device marketed in the usa. A review of the device history records has been requested. 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 fell on (b)(6) 2018 resulting in an influx of a dislocated pertrochanteric and subtrochanteric femur fracture on the right, a subcapital humeral fracture on the right, and a distal radical fracture on the right. Patient was implanted with the proximal femoral nail antirotation (pfna) nail on the same day. X-rays taken on (b)(6) 2018 revealed that the nail was broken. Patient was returned to surgery on (b)(6) 2018 for removal of the broken device. It was further reported patient died on (b)(6) 2018. The patient died 4 days after the revision in the course of a fulminant postoperative ards. The revision was successful. The death is indirectly attributed to the pfna nail breakage, which necessitated the revision surgery placing the patient at additional medical risk. It is likely that the death was a result of the known comorbidities and age related infirmity and not related to the pfna malfunction itself. Concomitant devices reported: pfna blade (02. 027. 034s, lot l784517, quantity 1); locking screw (part number unknown, lot number unknown, quantity unknown); cable (part number unknown, lot number unknown, quantity unknown). This report is for one (1) pfna nail. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Dhr review was completed. Part: 272. 280s. Lot: l740424. Manufacturing site: (b)(4). Release to warehouse date: 01. Feb. 2018. Expiry date: 01. Jan. 2028. The device history record shows this lot of 10 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. The raw material certificate was reviewed and the used material was according to specification for implants for surgery. 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 a review of the received x-ray. Clinical assessment states: the timeline of this patient¿s medical course speaks for itself. The information in this complaint record reasonably suggests that a device malfunction did occur and regardless of misuse, may have caused or contributed to a death. At the time of this review, the information available indicates the patient was initially implanted with pfna. Revision surgery was required 4 months due to a broken pfna nail. The revision surgery removing the broken pfna nail and inserting a proximal femoral plate was successfully completed. It was reported that the patient had multiple co-morbidities (osteoporosis, multiple embolic cerebral infarctions in the stromal area of the right cerebral artery, chronic anemia) and subsequently died 4 days after the revision surgery. The death is indirectly attributed to the pfna nail breakage, which necessitated the revision surgery placing the patient at additional medical risk. It is likely that the death was a result of the known comorbidities and age related infirmity and not related to the pfna malfunction itself. In addition, the proximal femoral plate and screws placed in at the successful revision surgery did not malfunction and did not cause or contribute to the ultimate death of this patient. The x-rays was reviewed and it can be confirmed that the pfna long is broken. 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 NamePFNA Ø10 LONG R 130° L340 SST
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 wright lane east
west chester, PA 19380
6103142063
MDR Report Key7861632
MDR Text Key119730529
Report Number8030965-2018-56204
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSZ
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,Followup
Report Date 08/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number272.280S
Device Lot NumberL740424
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 Received05/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2018
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: 09/10/2018 Patient Sequence Number: 1
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