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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PROTECT SLEEVE 16/11 F/PFNA BLADE ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH PROTECT SLEEVE 16/11 F/PFNA BLADE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 356.818
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2021
Event Type  malfunction  
Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank. Additional narrative: device history (lot). Part: 356. 817. Lot: 2623244. Manufacturing site: (b)(4). Release to warehouse date: 18 aug 2010. Due to the age of more than 10 years of the complained device a wear or use related root cause is the most likely reason of the complained malfunction. Per franchise complaint product investigation procedure is for complaints for which a non-manufacturing related probable cause has been identified no manufacturing record evaluation is required. As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications. The overall complaint was confirmed for buttress/compr-nut f/pfna blade. There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities. 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) 2021, the patient underwent open reduction internal fixation (orif) surgery for trochanteric femur fracture. The device with a femoral neck-shaft angle of 125 degree was attached for the nail of angle of 130 degree; however the inserter could not be removed from the proximal femoral antirotation nail (pfna) blade. The surgeon was able to somehow take the blade together with the inserter out, but the blade did not come off the inserter after taking them out from the patient¿s body. After attaching the correct device, the surgery was completed within thirty (30) minutes delay with another blade inserted using another inserter. Patient outcome is reported as stable. No further information is available. This is report 3 of 4 for complaint (b)(4).
 
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Brand NamePROTECT SLEEVE 16/11 F/PFNA BLADE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES 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 Key12332789
MDR Text Key267044630
Report Number8030965-2021-06756
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
Report Date 08/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number356.818
Device Lot Number2287584
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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