MAUDE Adverse Event Report: SYNTHES USA; BIT, DRILL

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation, as it has been reportedly discarded by the facility.No service history review can be performed because the part lot/serial number is unknown and cannot be traced.The manufacture date is unknown.The service history review is unconfirmed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Information reported on maude 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 Description

This report is against user facility medwatch number mw5067004, a copy is attached.The only information contained in this report is correction or additional information.There was no reported delay and noadditional medical intervention was required.During the procedure an unknown synthes 1.1mm orthopedic drill bit broke and the tip became embedded in the patient¿s bone.The surgeon did not attempt to retrieve the embedded device for concern of causing further damage.There was a back-up drill bit for the surgeon to successfully complete the procedure.The drill bit fragment that was not embedded in the patient was discarded.The patient outcome was reported stable.At some point when the patient returns to have the hardware removed the surgeon will attempt to remove the embedded fragment.Concomitant devices reported: drill (unknown part and lot numbers) quantity:1 this is report 1 of 1 for (b)(4).

Manufacturer Narrative

Without a lot number the device history records review could not be completed.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

Mw5069484.

• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6658430
• MDR Text Key: 78126462
• Report Number: 2520274-2017-11831
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 05/23/2017

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
• Initial Date Manufacturer Received: 05/23/2017
• Initial Date FDA Received: 06/21/2017
• Supplement Dates Manufacturer Received: 07/17/2017
• Supplement Dates FDA Received: 07/17/2017
• 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
• Patient Age: 38 YR
• Patient Weight: 90