MAUDE Adverse Event Report: SYNTHES USA; BIT, DRILL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 03/07/2016

Event Type  Injury  

Manufacturer Narrative

Patient id/initials, age/date of birth, and weight are unknown.This report is for an unknown drill bit/unknown lot.Part and lot numbers are unknown; udi number is unknown.Implant and explant dates: device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during an open reduction internal fixation of a lisfranc fracture a 1.6 mm kirschner wire was placed for provisional fixation.During drilling of a 4 mm cortex screw into the bone, the drill bit interfaced with the kirschner wire and created a bend in the wire.The drill bit remained intact.As the kirschner wire was being removed using oscillating motion, the kirschner wire broke in half at the bend previously created by the interface with the drill bit.An additional incision was created to remove half of the wire.There was nothing retained in the bone.There was an approximately thirty (30) minute delay in surgery.There was no further patient harm reported.The surgery was completed successfully.This report is for an unknown drill bit.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

It was determined upon review of the two (2) received metal pieces that both belonged to the k-wire.The reported (unknown) drill bit was not returned for evaluation.Product investigation summary: the drill bit referenced in this complaint was not returned for evaluation.Device 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 further clarified by the reporter that the drill bit had hit the k-wire during the procedure.

• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5513564
• MDR Text Key: 40777682
• Report Number: 2520274-2016-11762
• Device Sequence Number: 1
• Product Code: HTW
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2016
• 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 Outcome(s): Required Intervention