MAUDE Adverse Event Report: SYNTHES RARON 3.5MM RECONSTRUCTION PLATE 9 HOLES/106MM; APPLIANCE,FIXATION,SPINAL INTERLAMINAL

Catalog Number 245.190

Device Problem Bent (1059)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient id, date of birth and weight were not provided for reporting.Date of event was reported as (b)(6) 2017.It is unknown if it is the implant date or the date it was noted to be bent.Additional device product code: ktw.Date of implant is unknown.It was reported that device will be returned.Therefore it was assumed that the revision surgery occurred.It is unknown when the device was explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Reporter facility contact number was not provided.(b)(4).Device history records review was completed for part# 245.190, lot# l003691.Manufacturing location: (b)(4), manufacturing date: jun 06, 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 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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on an unknown date, the device was placed on the patient's collarbone.One week after the placement, during a review the doctor noticed that the straight reconstruction plate was bent.Patient outcome was not reported.Concomitant reported part: screws.This report is for one (1) 3.5 mm reconstruction plate 9 holes/106 mm.This is report 1 of 1 for (b)(4).

Manufacturer 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

Corrected information was received: the revision procedure occurred on (b)(6) 2017.

Manufacturer Narrative

(b)(6).The device was received, the investigation could not be completed, and 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.

Event Description

It was reported the initial implant date was (b)(6) 2017.A revision procedure took place on (b)(6) 2017 and was successfully completed.Reported the patient progress has been good.

Manufacturer Narrative

A manufacturing evaluation was completed: the plate is strongly bent.Marks and scratches are visible on the surface.The device-history-record (dhr) does not show any abnormalities.Everything was produced in specification as it should.Measurements of the critical features were taken on the complaint part.No manufacturing related issue was identified and/or confirmed.A product investigation was completed: the visual inspection has shown that the plate is strongly bent and has visible marks and scratches on the entire surface.The review of the production histories revealed that this device was manufactured in june 2016 according to the specifications.No manufacturing related issues that would have contributed to this complaint were found.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.All measured device feature were measured which were found to be within specification.No design related issues were identified that would contribute to this complaint issue.Without further clinical information the exact cause cannot be determined.The complaint is determined not to be a result of a product related deficiency.No indication for product related issue was found.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.

• Brand Name: 3.5MM RECONSTRUCTION PLATE 9 HOLES/106MM
• Type of Device: APPLIANCE,FIXATION,SPINAL INTERLAMINAL
• Manufacturer (Section D): SYNTHES RARON; kanalstrasse west 30; raron CH394 2; SZ CH3942
• Manufacturer (Section G): SYNTHES RARON; kanalstrasse west 30; raron CH394 2; SZ CH3942
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6700489
• MDR Text Key: 79595806
• Report Number: 3006126083-2017-10029
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 07611819009042
• UDI-Public: (01)07611819009042(10)L003691
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 245.190
• Device Lot Number: L003691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN QUANTITY OF UNKNOWN SCREWS
• Patient Outcome(s): Required Intervention