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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA NAIL; IMPLANT
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STRYKER TRAUMA KIEL UNKNOWN GAMMA NAIL; IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Bone Fracture(s) (1870); Pain (1994)
Event Date 02/10/2020
Event Type  Injury  
Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
 
Event Description
The surgeon reported that the patient presented with pain and arthritis in the hip and because of this he undertook revision surgery for removal of a long gamma nail and conversion to a tha.Removal of the nail was a pre-requisite for the tha.The gamma nail had been implanted in approximately 2013.When the patient was opened the surgeon noticed that the most proximal of 2 distal screws was broken.The broken screw had been asymptomatic.The surgeon removed part of the screw, leaving the remaining piece of the screw in the bone.The surgeon did not attempt to remove the remaining piece of the screw.While taking the nail out, the surgeon struggled and tapped the nail.It is unclear whether the remaining screw was catching as the nail was removed.As the nail was removed, the patient sustained stress riser fracture which required an additional plating procedure.This plating resulted in a 2 hour surgical delay.The total delay to surgery was 2.5 hours.The tha was completed.
 
Event Description
The surgeon reported that the patient presented with pain and arthritis in the hip and because of this he undertook revision surgery for removal of a long gamma nail and conversion to a tha.Removal of the nail was a pre-requisite for the tha.The gamma nail had been implanted in approximately 2013.When the patient was opened the surgeon noticed that the most proximal of 2 distal screws was broken.The broken screw had been asymptomatic.The surgeon removed part of the screw, leaving the remaining piece of the screw in the bone.The surgeon did not attempt to remove the remaining piece of the screw.While taking the nail out, the surgeon struggled and tapped the nail.It is unclear whether the remaining screw was catching as the nail was removed.As the nail was removed, the patient sustained stress riser fracture which required an additional plating procedure.This plating resulted in a 2 hour surgical delay.The total delay to surgery was 2.5 hours.The tha was completed.
 
Manufacturer Narrative
Correction: refer to h6 device code.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.
 
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Brand Name
UNKNOWN GAMMA NAIL
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
DE  D-24232
MDR Report Key9788533
MDR Text Key193102189
Report Number0009610622-2020-00091
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
Type of Report Initial,Followup
Report Date 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/10/2020
Initial Date FDA Received03/04/2020
Supplement Dates Manufacturer Received03/12/2020
Supplement Dates FDA Received04/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age79 YR
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