MAUDE Adverse Event Report: SYNTHES JENNERSVILLE DHS®/DCS® GUIDE SHAFT WITH FLATS

Catalog Number 338.23

Device Problems Bent (1059); Material Distortion (2977)

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

Event Date 03/16/2015

Event Type  malfunction  

Event Description

It was reported that during a right hip open reduction internal fixation (orif) using a dynamic hip screw, the guide shaft, part # 338.21, bent and prongs could not engage the barrel over the shaft.A surgical delay of approximately 20 minutes was reported.Procedure was completed successfully.The damaged instrument was replaced during surgery.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: an investigation summary was performed.The investigation of the complaint articles has shown that:one part belonging to the dynamic hip and condylar screw system was received for this complaint.The technique guide was reviewed for proper use of these devices ((b)(4)).The technique for inserting the lag screw is to insert the coupling screw into the guide shaft and thread it into the end of the lag screw such that the tabs of the guide shaft seat into the slots of the lag screw.One dhs/dcs guide shaft, with flats (part# 338.23, lot#6647672, mfg 30may2011), was returned with the complaint that ¿during a right hip open reduction internal fixation (orif) using a dynamic hip screw, the guide shaft, part# 338.23, bent and prongs could not engage the barrel over the shaft.¿ upon receipt of this device it was seen that the dhs/dcs guide shaft, with flats (part# 338.23) has deformed prongs, these prongs are bent 30° off axis at an angle which indicates that this device was used for the removal.This device has likely been damaged due to excessive force during screw removal given the deformation pattern of the prongs.The complaint against this part is confirmed, however this complaint occurred as a result of improper use, as this device is not to be used for removal of implants for this system.The design of this device is adequate for its intended use and did not contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during a right hip open reduction internal fixation (orif) using a dynamic hip screw, the guide shaft, part # 338.23, bent and prongs could not engage the barrel over the shaft.A surgical delay of approximately 20 minutes was reported.

• Brand Name: DHS®/DCS® GUIDE SHAFT WITH FLATS
• Type of Device: GUIDE
• Manufacturer (Section D): SYNTHES JENNERSVILLE; 108 willowbrook lane; west chester PA 19382
• Manufacturer (Section G): SYNTHES JENNERSVILLE; 108 willowbrook lane; west chester PA 19382
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4639050
• MDR Text Key: 5574085
• Report Number: 3003787298-2015-10016
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 338.23
• Device Lot Number: 6647672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR