MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BOLT CUTTER HANDLE 13MM WIDTH ACROSS FLATS; INSTRUMENT,CUTTING,ORTHOPAEDIC

Catalog Number	391.780
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Date of event is unknown.Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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 the bolt cutter handle snapped and broke when cutting a schanz screw on an unknown date.It was unknown if there was a surgical or patient involvement.Concomitant device reported: 5.0 mm self-drilling schanz screw, 175 mm (part #: 294.785, lot #: unknown, quantity: 1).This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Investigation flow: broken.Visual inspection: the returned device was found to have a broken handle, which agrees with the complaint description.Two pieces were returned, however there are additional broken pieces of the handle which are missing.The handle also has multiple gouge marks which may be indicative of impact to the device.The shaft portion has minor surface wear which does not impact functionality.No new malfunctions were identified.Drawing/specification review: specification revision includes a lot number etch requirement; however, the lot number is not etched on the device, therefore it can be determined that the device was manufactured prior to the release of the revision.The device is over 19 years old, and a drawing from the time of manufacture is not available.Dimensional inspection: dimensional inspection will not be conducted due to the age of the device and the evidence of impact to the handle.Device history record (dhr) review is not possible as the lot number is unknown material/hardness review: material review through the dhr is not possible as the lot number is unknown.Based on the age of the device and the visual evidence of impact to the handle, there is no indication that a material issue contributed the complaint condition.No definitive root cause was able to be determined; however, the condition of the device indicates that it was handled roughly and the handle was likely impacted.19+ years of rough handling and use likely contributed to the complaint condition.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: BOLT CUTTER HANDLE 13MM WIDTH ACROSS FLATS
• Common Device Name: INSTRUMENT,CUTTING,ORTHOPAEDIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7783150
• Report Number: 2939274-2018-53331
• Device Sequence Number: 11227803
• Product Code: HTZ
• UDI-Device Identifier: 10886982198280
• UDI-Public: (01)10886982198280
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018

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: 391.780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE UNKNOWN