MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.5MM DRILL BIT/QC/GOLD/110MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number 310.25

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/13/2021

Event Type  Injury  

Manufacturer Narrative

Procode: additional product code: hsz, gff, hwe.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.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.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the tip of the 2.5mm drill bit broke inside the patient when drilling for a 3.5mm screw.Surgeon made the decision to leave the broken drill tip inside the bone.The broken drill bit was discarded and a new one was used.Procedure successfully completed without any delay.This report is for one (1) 2.5mm drill bit/qc/gold/110mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.5MM DRILL BIT/QC/GOLD/110MM
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11959353
• MDR Text Key: 263501245
• Report Number: 2939274-2021-02828
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 10886982186317
• UDI-Public: (01)10886982186317
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/14/2021

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
• Device Operator: Health Professional
• Device Model Number: 310.25
• Device Catalogue Number: 310.25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1