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 was used for treatment, not diagnosis.No patient involvement.Date of event is unknown.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Part # 03.809.972, lot # 7532654.Release to warehouse date: 17jan2014, supplier: (b)(4).No ncrs were generated during production.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 two oracle slap hammers are broken into two pieces and are worn out.This was discovered in sterile processing after the devices were sterilized.The second piece of one of the slap hammers was discarded by the hospital.No issues with the devices prior to discovery.No case or patient involvement.This is report number 1 of 2 for (b)(4).
Additional Manufacturer Narrative
A product investigation was performed on the returned subject devices.It was reported that two oracle slap hammers are broken into two pieces and are worn out.This was discovered in sterile processing after the devices were sterilized.The second piece of one of the slap hammers was discarded by the hospital.No issues with the devices prior to discovery.The threaded portion of the returned shafts were found to be broken.Only the shaft and slide components were returned for each device.The devices have surface wear which does not impact functionality.A visual inspection, drawing review and device history record (dhr) review were performed as part of this investigation.The complaint is confirmed.Replication of the complaint condition is not applicable as the device is already broken.Relevant drawings were reviewed during investigation.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.No definitive root cause was able to be determined.The devices are subject to impact during use and likely experienced excessive force causing breakage.There were no issues during the manufacture of this product that would contribute to this complaint condition.Date received by manufacturer on medwatch report (b)(4) should have been february 1, 2017.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.
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.

• Brand Name: ORACLE SLAP HAMMER
• Common Device Name: HAMMER,SURGICAL
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6371909
• Report Number: 1719045-2017-10171
• Device Sequence Number: 736219
• 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,Followup
• Report Date (Section B): 02/01/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/02/2017
• Supplement Report FDA Received Date: 03/30/2017; 03/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1