MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.5MM DRILL BIT/QC/GOLD/110MM; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Model Number 310.25

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

Patient Problem Foreign Body In Patient (2687)

Event Date 05/24/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: gff gfa hsz.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j sales representative.Investigation summary; photo investigation: the device was not returned.A photo-investigation was performed on the images.Upon inspecting the images provided, the 2.5mm drill bit was observed to be broken at the tip.However, the allegation of the broken part of the drill bit being embedded in the patient cannot be confirmed through the provided x-ray images.The root cause for the reported issue cannot be determined from the available information.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition can be confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot part #: 310.25.Synthes lot #: u368972.Supplier lot #: u368972.Release to warehouse date: oct, 21 2020.Supplier: orchid unique.No ncr's generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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

It was reported that on (b)(6) 2021, the patient underwent for a surgery.During the surgery, a 2.5 drill bit broke and the tip was left in patient distal femur.It is unknown if there was a surgical delay.Procedure and patient outcome were unknown.This complaint involves (1) device.This report is for (1) 2.5mm drill bit/qc/gold/110mm.This report is 1 of 1 for (b)(4).

• Brand Name: 2.5MM DRILL BIT/QC/GOLD/110MM
• Type of Device: INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
• 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: 12026129
• MDR Text Key: 263859119
• Report Number: 2939274-2021-03049
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10886982186317
• UDI-Public: (01)10886982186317
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 310.25
• Device Catalogue Number: 310.25
• Device Lot Number: U368972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 103