MAUDE Adverse Event Report: SYNTHES MONUMENT POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number	03.632.037
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.There was no reported patient involvement associated with the complained event.Device is an instrument and is not implanted/explanted.The subject device has been received and is currently undergoing investigation.The results of the investigation are pending completion.A device history record review was performed for the subject device lot.Manufacturer: synthes monument.Date of manufacture: nov 23, 2011.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 reported that the small silver component on the tip of the shaft of the polyaxial head placement tool popped off during sterile processing.There was no patient or surgical involvement.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A product development investigation was performed for the subject device (polyaxial head placement tool for matrix, part number 03.632.037, lot number 6707905).The subject device was returned with the complaint condition stating the small silver component on the tip of the shaft of the polyaxial head placement tool popped off during sterile processing.There was no patient or surgical involvement.The polyaxial head placement tool (03.632.037) is used in the matrix degenerative and deformity spine systems per the associated technique guides.The tool is used to retrieve a polyaxial head from an implant module and place it over a matrix bone screw.The technique guides state that, to ensure the polyaxial head is securely attached to the bone screw, the user is to gently lift up on the placement tool and angulate the polyaxial head.In order to remove the instrument from the polyaxial head, the button on the proximal end of the device is pressed.The returned instrument was examined and the complaint condition was able to be confirmed as the blocker was received broken from the outer shaft.Further examination showed evidence of laser welding both the blocker and the distal portion of the outer shaft.The complaint condition was unable to be replicated due to post-manufacturing damage.No definitive root cause was able to be determined.The blocker is only laser welded to half of the outer shaft body, making it vulnerable to breakage in the area of the laser weld; as such the failure mode is consistent with rough handling.Relevant drawings for the returned instrument were reviewed: top-level and blocker.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A device history review was performed for the returned instrument¿s lot number and no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6256375
• Report Number: 1719045-2017-10027
• Device Sequence Number: 426896
• Product Code: LXH
• UDI-Device Identifier: 10705034718958
• UDI-Public: (01)10705034718958(10)6707905
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2016

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: 03.632.037
• Device Lot Number: 6707905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2017
• Supplement Report FDA Received Date: 02/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1