MAUDE Adverse Event Report: SYNTHES RARON WASHER 13.0MM; BOLT, NUT, WASHER

Catalog Number 419.990

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 11/18/2016

Event Type  Injury  

Manufacturer Narrative

Device broke intra-operative; device was not implanted/explanted.(b)(6).(b)(4).Manufacturing location: (b)(4).Manufacturing date: june 08, 2016.No non-conformance reports were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a surgery for femoral neck fixation was performed on (b)(6) 2016.After the screw was fixed it was noted that the washer was broken during x-ray photography.The surgeon had to remove the broken washer and insert and fix the screw again to complete the procedure.The surgery was prolonged about two (2) hours.Patient condition is stable.Concomitant reported part: screw (part/lot unknown, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product investigation has been completed for part# 419.990, lot# 9955479.One washer 13.0mm device was returned to manufacturer for investigation.A visual inspection and device history records review has been completed as part of this investigation.The received device is broken in half and the inside diameter is noted to be deformed.Because of the damage, only the thickness could be checked and found to meet the specifications.The specification as per the valid technical drawing and the measured thickness with caliper is 1.49mm.The device history records review shows that the device met fully to our specifications at the time of manufacturing in june 2016 and there were no issues that would contribute to this complaint condition.The manner of deformed inside diameter suggests that the washer broke because of mechanical overloading.No manufacturing related issue was identified and/or confirmed.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: WASHER 13.0MM
• Type of Device: BOLT, NUT, WASHER
• 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: 6215842
• MDR Text Key: 63651028
• Report Number: 3006126083-2016-10050
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 07611819031807
• UDI-Public: (01)07611819031807(10)9955479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMEND
• 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
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 419.990
• Device Lot Number: 9955479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1 UNKNOWN SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR