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

Model Number 51-430-95-07

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949)

Patient Problem Skull Fracture (2077)

Event Date 09/06/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that an incorrect screwdriver was used to activate a set of mandibular distractors implanted into a patient's skull.Procedure involved implantation of two mandibular distractors onto patient's skull to treat bilateral coronal craniosynostosis.Initial reporter (uf/importer report # (b)(4) ) incorrectly reported that distractors and screwdriver were mislabeled and that the screwdriver "that came in the tray was the wrong size for the tray." in fact, there are multiple different screwdrivers and mandibular distractors contained in the zurich mandibular distraction set.Both the screwdriver and distractors used in this procedure were labelled correctly.The incorrect screwdriver was chosen to activate the distractors implanted into patient, resulting in the distractor expanding at a greater than desired rate.The head size and configuration of the activation arm in the zurich mandibular distractors are uniform and are dictated by design functionality, such that zurich distraction screwdrivers are compatible with the activation arm.The speed of distraction for any zurich mandibular distractor is governed by the design of the distractor, not the screwdriver used to activate it.

Event Description

It was reported that an incorrect screwdriver was used with implanted mandibular distractors in a cranial procedure.

Manufacturer Narrative

An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.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 root cause for this failure was an incorrect use 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: DISTRACTION
• Type of Device: PATIENT SCREWDRIVER
• Manufacturer (Section D): KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KLS MARTIN L.P.; p.o. box 16369; jacksonville FL 32245
• Manufacturer Contact: jennifer damato ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 12593930
• MDR Text Key: 275390296
• Report Number: 9610905-2021-00091
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00888118081445
• UDI-Public: (01)00888118081445
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLS 1 EXEMPT
• Exemption Number: 2017029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

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: 51-430-95-07
• Device Lot Number: KEO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• 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: 5 MO
• Patient Sex: Female