MAUDE Adverse Event Report: SYNTHES MONUMENT ORACLE SLAP HAMMER; HAMMER,SURGICAL

Catalog Number	03.809.972
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Manufacturing site: part#: 03.809.972, lot#: 7532654.Release to warehouse date: 17-jan-2014.Expiration date: not applicable.Supplier: (b)(4).No nonconformances 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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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
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 5 of 5 for com-(b)(4).
Additional Manufacturer Narrative
Additional narrative: device is not expected to be returned for manufacturer review/investigation.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: ORACLE SLAP HAMMER
• Common Device Name: HAMMER,SURGICAL
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6311821
• Report Number: 1719045-2017-10089
• Device Sequence Number: 18841213
• Product Code: FZY
• UDI-Device Identifier: 10705034726908
• UDI-Public: (01)10705034726908(10)7532654
• 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,Followup
• 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: 03.809.972
• Device Lot Number: 7532654
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2017
• Supplement 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