MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG SURGICAL PRESS

Model Number 184-360/00

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is in process.

Event Description

It was reported that during surgery the femoral head press assembly got cross threaded and will no longer turn.There were no consequences to the patient reported.

Event Description

It was reported that during surgery the femoral head press assembly got cross threaded and will no longer turn.There were no consequences to the patient reported.

Manufacturer Narrative

The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time period, when the item was produced.The reported event was confirmed through visual inspection.The damage of the press indicates that it has not been adequately lubricated before use.According to the instructions for use hinge joints, screw threads and other moving parts must be coated with physiologically safe oil after cleaning and thermal disinfection.

• Brand Name: SURGICAL PRESS
• Type of Device: SURGICAL PRESS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 7556192
• MDR Text Key: 109759476
• Report Number: 3004371426-2018-00002
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K171273
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 184-360/00
• Device Catalogue Number: 184-360/00
• Device Lot Number: B809071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2018
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: 08/02/2018
• Supplement Dates FDA Received: 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1