MAUDE Adverse Event Report: SYNTHES (USA) DHS/DCS LAG SCREW 12.7MM THREAD/90MM

Catalog Number 280.900

Device Problem Fitting Problem (2183)

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

Event Date 03/18/2011

Event Type  malfunction  

Event Description

It was reported that during a hip fracture procedure, the surgeon had just began to insert the dhs/dcs lag screw and discovered the 135 degree dhs plate standard would not fit with the screw.It was reported that the surgeon did not insert any further and removed the lag screw and checked outside the body for fit.The screw and plate still did not fit together.It was reported that the surgeon selected another lag screw and dhhs plate to insert and complete the procedure.It was reported that an additional time of twenty (20) minutes was needed as the scrub technician was having difficulties fitting the new plate and lag screw together.This complaint is against the lag screw.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities.Device listed in this report is used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.A review of the device history shows revealed no complaint related anomalies.Subject device was received with a lag screw.An inspection of the device shows damage to the slotted end of the shaft.The slotted end of the shaft is slightly mushroomed and appears to be out of round.The slot also shows deformation due to the damage.No other damage is noted on the part.The damage to the lag screw occurred post manufacturing, as all pertinent features to this complaint are conforming.Therefore the complaint against the lag screw is indeterminate.

• Brand Name: DHS/DCS LAG SCREW 12.7MM THREAD/90MM
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: 1690 russell rd.; paoli, PA 19301
• MDR Report Key: 4368510
• MDR Text Key: 19798220
• Report Number: 2520274-2014-05119
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/11/2011

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 Catalogue Number: 280.900
• Device Lot Number: 6455493
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/05/2011
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2011
• Initial Date FDA Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1