MAUDE Adverse Event Report: SYNTHES GRENCHEN 135 DEG DHS® PLATE-STANDARD BARREL 2 HOLES/46MM; APPLIANCE, FIXATION, NAIL

Catalog Number 281.102

Device Problems Fitting Problem (2183); Failure to Align (2522)

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

Event Date 11/26/2014

Event Type  malfunction  

Event Description

It was reported the 135 degree dynamic hip screw (dhs) plate standard barrel 2 holes 46mm, dynamic hip screw/dynamic condylar screw (dhs/dcs) coupling screws and dhs/dcs guide shaft that the 5 plate would not go in the screw.The coupling screw broke and guide shaft bent.The fragments were retrieved.The patient status/outcome is unknown.There was no surgical delay.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Additional product code: jdo.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 history review: manufacturing location: (b)(4)- manufacturing date: august 25, 2014 - no non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device 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

Subject device has been received and is currently in the evaluation process.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

(b)(4).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: product evaluation: the 338.210 dhs/dcs guide shaft, 338.20 dhs/dcs coupling screw, short, and 281.102 dhs plate, standard barrel, 135 degrees are devices routinely used in the dhs/dcs dynamic hip and condylar screw system.The returned 281.102 dhs plate is in good condition, despite some deformation on the inner portion of the distal barrel opening of the plate.The device was returned and reported to have not fit over the already inserted lag screw.This condition is unconfirmed; however, the deformation along the distal portion of the barrel is indicative of the flat surfaces of the barrel not having been aligned with the flat surfaces along the lag screw.This would have led to the rounded portions of the lag screw being forced into the flat surfaces of the barrel causing the deformation.It is likely that this misalignment led to the complaint condition.Drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.It is likely that the lag screw and plate barrel were misaligned leading to this unconfirmed complaint; however, this complaint is not a result of any design related deficiency.Device 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.

• Brand Name: 135 DEG DHS® PLATE-STANDARD BARREL 2 HOLES/46MM
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen PA 19380 CH2; SZ 19380 CH25
• Manufacturer (Section G): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH25 40; SZ CH2540
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4366684
• MDR Text Key: 5118407
• Report Number: 2520274-2014-15612
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK791619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/01/2014

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: 281.102
• Device Lot Number: 9094870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2015
• Initial Date FDA Received: 12/29/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/22/2015; 01/29/2015; 02/10/2015; 03/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17 YR