MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM CANNULATED DRILL BIT LARGE QC/300MM; BIT,DRILL

Catalog Number	310.63
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary product was not returned.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.Without a lot number the device history records review could not be completed.Product was not returned.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 on an unknown date that during a slipped capital femoral epiphysis (scfe) surgery with 6.5 cannulated screws on (b)(6) 2019, a tiny piece of the tip of a cannulated drill bit broke off into the patient.As the drill bit was being advanced over the guide wire and into the bone, it hit the wire and a small piece of the drill bit broke off.The broken fragment was retained in the patient's body and no retrieval attempt was made as it was not in the way.There was no reported surgical delay.Unable to remove fragments.The surgery was completed by placing the screw over the wire in the correct place.There was no adverse consequence to the patient.Concomitant device reported: unknown guide wire (part# unknown, lot# unknown, quantity# 1).This is report 1 of 1 for (b)(4).

• Brand Name: 5.0MM CANNULATED DRILL BIT LARGE QC/300MM
• 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: 9312323
• Report Number: 2939274-2019-62131
• Device Sequence Number: 11253240
• Product Code: HTW
• UDI-Device Identifier: 10886982186812
• UDI-Public: (01)10886982186812
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2019

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 Catalogue Number: 310.63
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR