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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA-MAHWAH UNKNOWN GAMMA NAIL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA-MAHWAH UNKNOWN GAMMA NAIL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number UNK_KIE
Device Problems Break (1069); Fracture (1260)
Patient Problems Failure of Implant (1924); Implant Pain (4561)
Event Date 02/25/2022
Event Type  Injury  
Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.Device remains implanted in patient.
 
Event Description
Customer reported that patient presented acute onset severe left hip pain.Initial x-ray reported as normal.Following an ongoing significant pain, a further x-ray confirmed a implant failure.Plan for non-operative management and close observation.
 
Event Description
Customer reported that patient presented acute onset severe left hip pain.Initial x-ray reported as normal.Following an ongoing significant pain, a further x-ray confirmed a implant failure.Plan for non-operative management and close observation.
 
Manufacturer Narrative
Please note the correction to b2.The reported event could be confirmed, although the device was not returned but a few x-rays were shared which confirms the alleged failure.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.A formal medical opinion was sought for the provided x-rays from an independent healthcare professional.To a question regarding the probable reason for the breakage of the nail, the hcp opined: "there is no clear reason for the failure.The fracture pattern is pretty straight, the positioning of the lag screw and the nail is okay [almost center/center in both plains].What we can see from the first intraoperative image is, that the neck fragment is restored in a valgic positioning with the fracture gap being a little bit widened caudally.This may have contributed to a prolonged consolidation.The bone seems to react normal with a reasonable amount of callus formation around the fracture gap." the available information is not sufficient to determine the exact root cause of the failure.More information as well as the affected device must be available to determine the exact reason.If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
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Brand Name
UNKNOWN GAMMA NAIL
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM   D-24232
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key14589620
MDR Text Key293249965
Report Number0009610622-2022-00214
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other;
Patient Age81 YR
Patient SexFemale
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