MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HAMMER 700 GRAMS; HAMMER, SURGICAL

Catalog Number	399.43
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportedly there was no patient involvement.Date of event: 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.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 during sterile processing on unknown date, it was noticed that the hammer handle broke.No surgical involvement was noted.No patient involvement.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: reporter facility name, address and phone number.A product investigation was conducted.Visual inspection: the handle was found to be broken into multiple pieces.The break runs through the dowel pin.Two large pieces were returned; however, additional pieces were missing.The received condition agrees with the complaint condition.Drawing/specification review: the relevant drawings were reviewed during investigation.It was determined that the device was manufactured prior to september 2003; however, the exact revision could not be determined.Dimensional inspection: the thickness of the handle was measured and is within the specification per relevant drawing.Material/hardness review: as the lot number was not known a dhr review could not be performed to confirm the material.No definitive root cause was able to be determined; however, it is likely that the device experienced wear and rough handling from over 15 years of use.There is no indication that a manufacturing issue contributed to the complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.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: HAMMER 700 GRAMS
• Common Device Name: HAMMER, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7796568
• Report Number: 2939274-2018-53365
• Device Sequence Number: 13738950
• Product Code: FZY
• UDI-Device Identifier: 10886982202819
• UDI-Public: (01)10886982202819
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2018

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: 399.43
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1