MAUDE Adverse Event Report: SYNTHES GRENCHEN 4.5MM CURVED BROAD LCP® PLATE 16 HOLES/300MM; PLATE,FIXATION,BONE

Catalog Number 226.662

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 08/23/2016

Event Type  Injury  

Manufacturer Narrative

Additional device product code used hwc.(b)(6).(b)(4).Device history records review was completed for part # 226.662, lot # 9908501.Manufacturing location: (b)(4), manufacturing date: april 12, 2016.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follow: it was reported that a plate fractured post-operatively.On (b)(6) 2016, patient underwent revision procedure and removed the plate.No fragments remained in the patient.No information about patient condition and outcome is available.This report is for one (1) plate.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Manufacturing evaluation was completed for part # 226.662, lot # 9908501.The product was returned in a packaging different from the original packaging.The laser marking was readable.The plate shows scratches and abrasion.Also the threaded holes show strong abrasion.The plate is broken at the location of drill hole 9.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.All dimensions relevant for the function of the product were measured, and fulfill the specifications.The raw material certificates were checked and it was found that all used raw material fulfilled the specifications.Based on this the complaint is rated as confirmed but not valid from the point of view of the manufacturing site.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 the breakage occured while patient was walking on crutches on (b)(6) 2016.The breakage happened on a hole that was not occupied by a screw.

• Brand Name: 4.5MM CURVED BROAD LCP® PLATE 16 HOLES/300MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH254 0; SZ CH2540
• Manufacturer (Section G): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH254 0; SZ CH2540
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6087394
• MDR Text Key: 59451552
• Report Number: 3009450884-2016-10112
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 226.662
• Device Lot Number: 9908501
• Other Device ID Number: (01)07611819290624(10)9908501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 75