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

Model Number	26-975-39-07
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reference exemption number e2017029.
Event or Problem Description
It was reported that a screwdriver broke and a portion remained implanted.
Additional Manufacturer Narrative
Manufacturer concluded that excessive mechanical torsional stress could cause the screwdriver blades in a single manufacturing lot to deform or fracture at tip.Of the affected lot, a quantity of two screwdriver blades distributed in the u.S.Are being removed from market.Possible deformation or breakage of surgical screwdriver tips due to excessive mechanical torsional force is a known inherent risk of the device.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: SCREWDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• MDR Report Key: 9885083
• Report Number: 9610905-2020-00032
• Device Sequence Number: 14154131
• Product Code: HXX
• UDI-Device Identifier: 00888118054333
• UDI-Public: (01)00888118054333
• Combination Product (Y/N): N
• Initial Reporter Country: WZ
• PMA/510(K) Number: CLS 1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020
• Report Date (Section F): 02/26/2020

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: 26-975-39-07
• Device Lot Number: KDA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 04/24/2020
• 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: 72 YR