MAUDE Adverse Event Report: SYNTHES MONUMENT ROD INTRODUCER; MISC ORTHO SURGICAL INSTR

Catalog Number	03.616.048
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.Date of event is unknown.Implant and explant dates: device is an instrument and is not implanted/explanted.Initial reporter phone number: (b)(6).Device history record review was performed for part# 03.616.048 lot# h036902: release to warehouse date: 13-jul-2016, supplier: (b)(4): no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.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.
Event or Problem Description
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that there was a functional issue of a tip of a rod holder.The rod cannot be attached as usual.The issue occurred preoperatively, therefore no patient involvement.Concomitant device reported as: unknown rod (part: unknown, lot: unknown, quantity: 1) this is report 1 of 1 for (b)(4).
Additional 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 or Problem Description
It was noted that the device was unused.When the device was being reviewed by the manufacturer, it was noted that the pivot screw was missing.
Additional Manufacturer Narrative
Product development investigation has been completed.The instrument was inspected in customer quality where it was noticed the pivot pin in the handle is missing from the device which may impact functionality of the device.Replication of the complaint condition is not applicable as the pin is already missing.The instrument was sent to the supplier for investigation.Supplier investigation concluded that all (b)(4) parts functioned properly.The one (1) returned part was also checked with the required functional gages instructed upon the print, and the one (1) returned part functioned properly and conformed to the print requirements and print instruction.In addition, the lot of (b)(4) instruments later passed functional testing at depuy synthes before being released to the field, which further demonstrates these instruments were functionally conformant when received.It is therefore our conclusion that the instruments met agreed upon criteria at the time of delivery to depuy synthes.No manufacturing related issue was identified and/or confirmed.A root cause could not be determined as the circumstances surrounding the complaint are unknown.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: ROD INTRODUCER
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6165956
• Report Number: 1719045-2016-10903
• Device Sequence Number: 10776274
• Product Code: LXH
• UDI-Device Identifier: 10705034716381
• UDI-Public: (01)10705034716381(10)H036902
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2016

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: 03.616.048
• Device Lot Number: H036902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/21/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/12/2016
• Supplement Report FDA Received Date: 01/31/2017; 03/28/2017
• 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: ONE (1) UNKNOWN ROD