MAUDE Adverse Event Report: SYNTHES MONUMENT HOLDING SLEEVE-STANDARD WITH STOP FOR MATRIX; CANNULA,SURGICAL,GENERAL & PLASTIC SURGERY

Catalog Number	03.632.123
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportedly there was no patient involvement.Device is an instrument and is not implanted/explanted.Device history records review was completed for part# 03.632.123, lot# 7474959.Supplier: (b)(4), release to warehouse date: jan 14, 2014, jun 02, 2014.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.Product investigation was completed.A visual inspection, device history record (dhr) review, and drawing review were performed as part of this investigation.The holding sleeve was returned with the tip broken.Standard with stop is one of ten (10) holding sleeves for the matrix spine system utilized during screw insertion.The matrix system is covered by three technique guides: matrix ¿ deformity, matrix-degenerative and matrix ¿ mis.Once the holding sleeve is engaged with the driver shaft, it can be threaded into the proximal end of the matrix screw by rotating the holding sleeve¿s green knob clockwise until it is fully engaged.Relevant drawings for the returned instrument were reviewed (both from the time of manufacture and present revision.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.No definitive root cause was able to be determined; the failure mode is consistent with the application of an off-axis load while engaging a screw.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 reported that a t-handle t25 stardrive shaft was stripped at the tip, the sleeve threads of a holding sleeve-standard with stop for matrix were stripped, the tip of the t-pal trial spacer has broken off, the tip of the t-pal spacer applicator has broken off, and the slap hammer broke into (2) pieces at the very lowest part of the hammer.This was discovered during routine inspection.There is no patient or case involved.This is report 6 of 6 for (b)(4).

• Brand Name: HOLDING SLEEVE-STANDARD WITH STOP FOR MATRIX
• Common Device Name: CANNULA,SURGICAL,GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6380795
• Report Number: 1719045-2017-10188
• Device Sequence Number: 783432
• Product Code: GEA
• UDI-Device Identifier: 10705034811130
• UDI-Public: (01)10705034811130(10)7474959
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 01/17/2017

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: 03.632.123
• Device Lot Number: 7474959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2017
• Initial Report FDA Received Date: 03/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1