MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM; BIT,DRILL

Catalog Number 03.010.078

Device Problems Break (1069); Failure to Align (2522)

Patient Problem No Code Available (3191)

Event Date 01/27/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Date returned to manufacturer.(b)(4).Used for: the complainant indicated that the drill bit broke intra-operative and a non-implant grade fragment is retained in the patient.Device history records review was conducted.The report indicates that the: dhr review.Part number: 03.010.078.Synthes lot number: pe03042.Supplier lot number: pe03042.Release to warehouse date: 29-jun-2017.Supplier: (b)(4).Manufacturing site: (b)(4).No ncrs were generated during production.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.

Event Description

It was reported that during a procedure for implanting a synthes lateral entry recon nail on (b)(6) 2018, a 4.5mm/6.5mm stepped drill bit large qc/485mm would not pass through the protection sleeves and the nail as it should.During this process, the drill bit broke inside of the patient bone.The broken fragment of the drill bit was retrieved and nothing was left in the patient.Also, a recon locking aiming arm for lateral entry femoral nails-ex was not working properly as it was misaligned with nail, but prior to insertion of femoral neck/head component, nail connection was checked and the aiming arm connection was secured as well.Two of the 11.5mm/8.5mm protection sleeve for recon locking and two 8.5mm/3.2mm wire guide for recon locking were also not guiding the drill bit properly through the nail.A standard insertion handle connected with the aiming arm wasn't working properly as the sales consultant heard some noise when the handle was being used.A cannulated connecting screw for standard insertion handle was not getting connected properly and a 5.0mm flexible shaft was not able to pass over a 2.5mm reaming rod.There was a surgical delay of 30 minutes and the surgeon was unable to implant recon screws into proximal femur.To complete the surgery, the surgeon opted to lock in dynamic hole by using a regular 4.9mm locking volt.The surgery was completed and the patient was stable after the surgery.This complaint involves six (6) devices.This report is 1 of 6 for (b)(4).

Manufacturer Narrative

Dhr review was completed.Part number: 03.010.078 synthes lot number: pe03042 supplier lot number: pe03042 release to warehouse date: 29-jun-2017 supplier: precision edge surgical products manufacturing site: monument no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, 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.

Manufacturer Narrative

Additional narrative: corrected data: these dates were reported as (b)(6) 2018 in the initial report (b)(4) in error.The correct date is (b)(6) 2018.Device is not expected to be returned for manufacturer review/investigation.Reporter name and occupation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.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.

• Brand Name: 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM
• Type of Device: BIT,DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7293277
• MDR Text Key: 101131331
• Report Number: 2939274-2018-50749
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10886982067487
• UDI-Public: (01)10886982067487(10)PE03042
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.078
• Device Lot Number: PE03042
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/07/2018
• Date Manufacturer Received: 03/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1