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

Model Number	25-449-07-91
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: mdr: 9610905-2018-00335.Reference exemption number e2017029.
Event or Problem Description
It was reported that a twist drill broke during use and the broken piece was not located.
Additional Manufacturer Narrative
The product was analyzed and it was determined that only a portion of the product was returned.There were no indications of material or manufacturing defects.An investigation was performed on the basis of complaint statistics.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.During the investigation the product lot number identified was reviewed in the device history records.The dhr review showed no discrepancies or anomalies.The failure root cause cannot be determined due to no device being returned.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.Updated lot number.Updated manufactured date.

• Brand Name: TWIST DRILL
• Common Device Name: TWIST DRILL
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• MDR Report Key: 8143597
• Report Number: 9610905-2018-00334
• Device Sequence Number: 13507166
• Product Code: HTW
• UDI-Device Identifier: 00888118040770
• UDI-Public: (01)00888118040770
• Combination Product (Y/N): N
• PMA/510(K) Number: CLS 1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2018
• Report Date (Section F): 12/01/2018

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: Health Professional
• Device Model Number: 25-449-07-91
• Device Lot Number: 33233760
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2018
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 03/09/2019
• 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: 24 YR