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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO T2 FEMUR 4,2X340 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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STRYKER TRAUMA KIEL DRILL, AO T2 FEMUR 4,2X340 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 1806-4260
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/14/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
 
Event or Problem Description
The customer reported that: "we had a problem during an intervention." on 08/09/2021 the customer added that: "during a surgery using the "femur nail" ancillary, the locking bit broke off in the bone during distal locking.The broken drill bit was removed without difficulty.No clinical consequences to date.".
 
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Brand Name
DRILL, AO T2 FEMUR 4,2X340 MM
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM  D-24232
MDR Report Key12413916
Report Number0009610622-2021-00676
Device Sequence Number20014704
Product Code LXH
UDI-Device Identifier04546540196767
UDI-Public04546540196767
Combination Product (Y/N)N
Initial Reporter CountryFR
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse Practitioner
Type of Report Initial
Report Date (Section B) 09/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number1806-4260
Device Catalogue Number18064260
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/09/2021
Initial Report FDA Received Date09/02/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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