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

Model Number 25-449-07-91

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: mdr: 9610905-2018-00335.

Event Description

It was reported that a twist drill broke during use and the broken piece was not located.

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
• Type of Device: TWIST DRILL
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 8143597
• MDR Text Key: 129666986
• Report Number: 9610905-2018-00334
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00888118040770
• UDI-Public: (01)00888118040770
• Combination Product (y/n): N
• PMA/PMN Number: CLS 1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 25-449-07-91
• Device Lot Number: 33233760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2018
• Initial Date Manufacturer Received: 12/01/2018
• Initial Date FDA Received: 12/07/2018
• Supplement Dates Manufacturer Received: 02/21/2019
• Supplement Dates FDA Received: 03/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR