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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT Ø3.2X180MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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STRYKER GMBH DRILL BIT Ø3.2X180MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Catalog Number 700356
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/10/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Disposed by customer.
 
Event or Problem Description
Customer reported that about 2cm of the drill bit has broken off and it is left in the patient.Unintended metal left in patient.The consultant orthopaedic surgeon made the decision based on lowest risk.During the follow up appointment, the patient has progressed well and is not concerned.
 
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Brand Name
DRILL BIT Ø3.2X180MM AO FITTING
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key8453744
Report Number0008031020-2019-00316
Device Sequence Number1341413
Product Code LXH
UDI-Device Identifier04546540413796
UDI-Public04546540413796
Combination Product (Y/N)N
Initial Reporter CountryGB
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 03/26/2019
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 Catalogue Number700356
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/04/2019
Initial Report FDA Received Date03/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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