MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0/10.0 STEP DRILL BIT CANN/LRG QC/435; REAMER

Model Number	357.403
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 on unknown date, the patient underwent for a surgery.During the surgery, step drill bit cann/large tip was broken off.It is unknown if there are procedure and patient involvement.This complaint involves one (1) device.This report is for (1) 6.0/10.0 step drill bit cann/lrg qc/435.This report is 1 of 1 for (b)(4).

• Brand Name: 6.0/10.0 STEP DRILL BIT CANN/LRG QC/435
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12079580
• Report Number: 2939274-2021-03271
• Device Sequence Number: 14415156
• Product Code: HTO
• UDI-Device Identifier: 10886982196262
• UDI-Public: (01)10886982196262
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2021

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 Model Number: 357.403
• Device Catalogue Number: 357.403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/28/2021
• Patient Sequence Number: 1