MAUDE Adverse Event Report: SYNTHES MONUMENT CONICAL EXTRACTION SCREW; TRAY, SURGICAL INSTRUMENT

Catalog Number	387.34
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).Device history records review was conducted.The report indicates that the: dhr review for part # 387.34 lot # u137709; supplier lot # (b)(4); release to warehouse date: 02aug2011; expiration date: n/a; supplier: (b)(4).Additional release to warehouse dates: 28sept2011 and 02nov2011.No ncrs were generated during production.Review of device history records showed that there were no issues during the manufacture of this 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.
Event or Problem Description
Device report from synthes on an event in (b)(6) as follows: it was reported on (b)(6) 2016, that the surgeon was removing a 7.3mm cannulated screw and the cannulated hexagonal screwdriver tip broke off and the tip of the conical extraction screw broke off.The surgeon was unable to remove the screw.The surgical procedural outcome is unavailable.There was a 5 minute surgical delay.The patient outcome/status is unavailable.There is no additional information available.Sales consultant indicates that there was an unknown time delay.This complaint involves 2 devices.Concomitant medical products: unknown screw 7.3mm cannulated part# unknown, lot#-unknown, quantity#1).This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Device is not expected to be returned for manufacturer review/investigation.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 or Problem Description
Procedure on (b)(6) 2017 was for revision of hardware removal on a pediatric case.Original date of implant and the cause of revision is unknown.The surgeon removed one cannulated screw through the femur head and noted that the removal of the second cannulated screw was unsuccessful.This report is 1 of 3 for (b)(4).

• Brand Name: CONICAL EXTRACTION SCREW
• Common Device Name: TRAY, SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6268371
• Report Number: 3003875359-2017-10032
• Device Sequence Number: 1057590
• Product Code: FSM
• UDI-Device Identifier: 10705034771083
• UDI-Public: (01)10705034771083(10)U137709
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 387.34
• Device Lot Number: U137709
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2017
• Supplement Report FDA Received Date: 01/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK SCREW 7.3MM CANNULATED PART & LOT # UNK, QTY 1