MAUDE Adverse Event Report: SYNTHES GMBH INSERT-INSTR F/DHS BLADE

Catalog Number 03.224.001

Device Problems Break (1069); Component Falling (1105); Contamination (1120); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 01/24/2014

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: during surgery, while the surgeon was inserting the connecting screw into the insertion instrument the threading tip of the connecting screw broke off and was left inside the blade.This happened when the dhs, dynamic hip system, blade was being attached to the connecting screw by the driver.At the same time, the blade fell on the floor and got dirty.As lag screws and insertion instruments were prepared as backups, the operation was completed using the lag screw instead of the blade.There were no broken parts left in the patient and a surgical delay of ninety minutes was reported.The product associated with this event has not been returned for investigation and no further information was provided.This is report 3 of 4 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Investigation could not be completed and no conclusion could be drawn as the device was not returned and no lot number was provided.Placeholder.

Manufacturer Narrative

Device is an instrument and is not implanted/explanted the investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.: a review of the device history records was performed and no complaint related issues were found.

Manufacturer Narrative

Additional information: this investigation has shown the returned instruments show that they threaded tip of the connecting screw is broken off.The damage is possibly indicative of too much continuous applied mechanical force on the connecting screw during usage.The technique guide (036.000.225) is used in order to eliminate such occurrences.This complaint is deemed invalid.

• Brand Name: INSERT-INSTR F/DHS BLADE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf PA CH-4 436; SZ CH-4436
• Manufacturer (Section G): SYNTHES GMBH; eimattstrasse 3; oberdorf CH-4 436; SZ CH-4436
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3639418
• MDR Text Key: 4179606
• Report Number: 2520274-2014-00739
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03.224.001
• Device Lot Number: 2263165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention