MAUDE Adverse Event Report: KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG TWIST DRILL

Model Number	25-452-05-91
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor was pre drilling holes in the peek implant while it was outside the patients head.Surgeon took his finger off of the drill before he was done drilling and the twist drill got stuck in the peek implant.When they were trying to remove it they rocked the twist drill back and forth and it broke a little piece of the twist drill off inside the peek implant.It wasn't sharp and wasn't all the way through to the other side.Doctor decided to leave it implanted in the peek and then proceeded to finish the case.The rest of the twist drill was discarded in the sharps container.
Additional Manufacturer Narrative
An investigation was performed on the basis of complaint statistics and data analysis as no device was sent back for evaluation.The complaint percentage falls within the design risk limits adhered to at klm.During the investigation the product lot number provided was reviewed in the device history records.The dhr review showed no discrepancies or anomalies.Due to no device being returned the root cause for the failure cannot be determined.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

• Brand Name: TWIST DRILL
• Common Device Name: DRILL
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strabe 10; muhlheim/donau, 78570 ; GM 78570
• MDR Report Key: 6339022
• Report Number: 9610905-2017-00024
• Device Sequence Number: 19036893
• Product Code: HTW
• UDI-Device Identifier: 00888118040978
• UDI-Public: (01)00888118040978
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2017

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
• Operator of Device: Physician
• Device Model Number: 25-452-05-91
• Device Lot Number: 33174621
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2017
• Supplement Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR