MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.8MM DRILL BIT/QC/165MM; BIT DRILL

Model Number	310.288
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.Investigation summary - the investigation could not be completed; no conclusion could be drawn.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 an unknown date, the surgeon complained that the locking compression plates (lcp) small fragment drill bits were dull or mis engineered.The quick coupling drill bit 110 mm,  quick coupling drill bit 165 mm, and  percutaneous drill bit were used for a case, swapped and switch to ensure new fresh bits were used.There was a surgical delay of ten (10) minutes.Procedure was successfully completed.There was no patient consequences.  this complaint involves three (3) devices.This report is 1 of 3 for (b)(4).

• Brand Name: 2.8MM DRILL BIT/QC/165MM
• Common Device Name: BIT DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8724877
• Report Number: 2939274-2019-58817
• Device Sequence Number: 13918292
• Product Code: HTW
• UDI-Device Identifier: 10886982186423
• UDI-Public: (01)10886982186423
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2019

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: 310.288
• Device Catalogue Number: 310.288
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 06/21/2019
• Patient Sequence Number: 1
• Patient Age: 82 YR