MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINK LUBINUS SPII - RASP STEM; FEMORAL STEM TRIAL PROSTHESIS

Model Number 130-553/06

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Type  malfunction  

Event Description

The pin on the top of the rasp stem which is fastened to the rasp handle (item no: 130-393/70) broke loose from the rasp stem under operation in the operation theatre.

Manufacturer Narrative

This complaint is justified.The complaint reason is a human error during the production process.Our complete stock of spii rasps was checked and no further missing welding seams have been discovered.We assess this case as a single incident.As a preventative action all concerned departments have been informed.The affected employees were trained on this complaint.We will keep the market monitored.This event occurred outside of the u.S.And involves a product that was manufactured outside of the u.S.However, because the affected product is also marketed in the u.S., waldemar link (b)(4) is submitting this mdr to ensure full compliance with 21 cfr part 803.Comp-04749.

• Brand Name: LINK LUBINUS SPII - RASP STEM
• Type of Device: FEMORAL STEM TRIAL PROSTHESIS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; hamburg 2233 9; GM 22339
• Manufacturer Contact: philipp kottmann ; barkhausenweg 10; hamburg 22339 ; GM 22339 ; 053575432
• MDR Report Key: 4273271
• MDR Text Key: 5300527
• Report Number: 3004371426-2014-00003
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130-553/06
• Device Catalogue Number: 130-553/06
• Device Lot Number: B309200
• Other Device ID Number: GMDN: 58481
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: COMPRESSORS (B)(4); LUBINUS SPII HANDLE FOR RASP STEMS AND BONE
• Patient Outcome(s): Hospitalization; Required Intervention