MAUDE Adverse Event Report: S.U.A. MARTIN GMBH &CO.KG V MUELLER LOVE-GRUENWALD FORCEPS MANUAL RONGEUR

Catalog Number 023050 / NL6092

Device Problems Fracture (1260); Dent in Material (2526)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

During inspection of the returned device notches were observed on the cutting edge of the tip. This type of damage is usually caused by misuse, such as grasping or cutting metallic objects, leading to overstress and breakage of the instrument. Review of manufacturing documents showed that the device conformed to specifications at the time of release. Hardness of the returned device was tested and found to conform to specifications. The device was manufactured and sold in 2006 and may have been in use for up to 13 years, well above its three-year lifetime.

Event Description

During revision of total knee replacement, the upper portion of the jaw of a pituitary forceps was seen breaking and falling into the femoral canal. It was immediately retrieved and the procedure was completed as planned. No patient issues were observed.

• Brand Name: V MUELLER LOVE-GRUENWALD FORCEPS
• Type of Device: MANUAL RONGEUR
• Manufacturer (Section D): S.U.A. MARTIN GMBH &CO.KG; uhlandstrasse 17; rietheim-weilheim, 78604 ; GM 78604
• Manufacturer (Section G): S.U.A. MARTIN GMBH &CO.KG; uhlandstrasse 17; rietheim-weilheim, 78604 ; GM 78604
• Manufacturer Contact: markus pauli ; uhlandstrasse 17; rietheim-weilheim, 78604 ; GM 78604
• MDR Report Key: 8811295
• MDR Text Key: 151724067
• Report Number: 8010386-2019-00002
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 023050 / NL6092
• Device Lot Number: XMEE12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 07/22/2019 Patient Sequence Number: 1