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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 31251180S
Device Problem Fracture (1260)
Patient Problem Fall (1848)
Event Date 11/28/2016
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device disposition is unknown.
 
Event Description
It was reported that gamma nail broke. The customer reported the case to the bfarm; the bfarm provided the report to stryker on (b)(6) 2016. In the initial report provided by the customer it is stated that the fracture is a pertrochanteric femur fracture. The patient was fallen after approx. 7 months ((b)(6) 2016) after implantation and the nail broke.
 
Manufacturer Narrative
The broken gamma3 trochanteric nail was classified as primary product during investigation. No deviations were found during review of the manufacturing and inspection documents (dhr). The nail returned was documented as faultless prior to distribution. During investigation no material, design or manufacturing related issues were found. The nail was found heavily drill marked at the posterior bridge within the proximal lag screw hole. The breakage line was found within the drill marked area. This misdrilling effect caused by the lag screw step drill did weak the posterior bridge significantly and caused a notching effect on the lateral side that favours the nail breakage. Lines of rest are visible on the bridge breakage surfaces; the bridges broke step by step. The lines of rest run from lateral towards medial. These lines of rest indicate (in combination with the found drill marks), that the nail breakage started at the posterior bridge at lateral. After the posterior bridge was full or main partly broken, the anterior bridge followed also step by step but quicker than the posterior bridge. The nail broke due to a fatigue fracture. Bearing points within the proximal nail hole indicate that loads were applied postoperatively to the implants over a long period; these loads did most likely also contribute to the nail breakage. The customer reported that the patient was fallen four weeks before the hospital follow up visit. Most likely the nail and bone got fractured due to a traumatic overload. Traumatic overloads, postoperatively loads and intra-operatively implant damages are adverse effects that can lead to implant breakages and are listed in the ifu and operative technique. Misdrilling could occur in case the target device was pre-damaged, instruments were not assembled correctly or bending forces were applied to the drill and/or target device during drilling. The operative technique includes that the target device shall be checked prior to every surgery. Because no manufacturer related issues were found the case is attributed to the patient, contributed by the user. Review of complaint history, capa databases and risk analysis did not identify any discrepancies. There are no open actions in place related to the reported event for the subject product(s). No non-conformity was identified.
 
Event Description
It was reported that gamma nail broke. The customer reported the case to the bfarm; the bfarm provided the report to stryker on (b)(6) 2016. In the initial report provided by the customer it is stated that the fracture is a pertrochanteric femur fracture. The patient was fallen after approx. 7 months ((b)(6) 2016) after implantation and the nail broke.
 
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Brand NameTROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6181128
MDR Text Key62597554
Report Number0009610622-2016-00629
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2021
Device Catalogue Number31251180S
Device Lot NumberK099D1E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/16/2016 Patient Sequence Number: 1
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