MAUDE Adverse Event Report: HEBUMEDICAL GMBH LEWIN SPINAL PERFORATING FORCEPS; SPINAL FORCEPS OR CLAMP

Catalog Number NL6960

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

The device is a neurosurgical forceps intended for use on the spine.However, when the reported event occurred the device was being used during an orthopedic procedure to remove the head of the femur, an intervention requiring a force much greater than the use intended by the manufacturer.Review of the device history record did not identify any related issues that may have contributed to the reported problem and device conformance to specs at time of release was confirmed.Hardness of the returned device was tested and found conforming to specifications.It can be concluded that inappropriate use of the device by application of excessive force and for an intended use different than the one specified by the manufacturer likely caused breakage of the device.

Event Description

The healthcare facility reported that the clamp jaws broke while being utilized to remove the head of the femur during the surgical case.The broken-off part of the jaws was retrieved using a c-arm.No patient injury known.

• Brand Name: LEWIN SPINAL PERFORATING FORCEPS
• Type of Device: SPINAL FORCEPS OR CLAMP
• Manufacturer (Section D): HEBUMEDICAL GMBH; badstrasse 8; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): HEBUMEDICAL GMBH; badstrasse 8; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: thomas butsch ; badstrasse 8; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 11805433
• MDR Text Key: 259989063
• Report Number: 9611112-2021-00001
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/11/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NL6960
• Device Lot Number: XHE 1P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention