MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE FOR 90° SCREWDRIVER; DRILL, BONE, POWERED

Model Number 03.505.004

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2018

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional product codes: dzj, hxx.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.Device was used for treatment, not diagnosis.

Event Description

It was reported that on (b)(6) 2018 a patient underwent an unknown procedure wherein a 90 degree drill would not drill intra-operatively.There was no known delay on the surgery and no other medical intervention done.The procedure was completed successfully and the patient status is good.This complaint involves two (2) devices.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device history records review was completed for part: 03.505.004, lot: 8165482.Manufacturing location: (b)(4).Release to warehouse date: mar 16, 2017.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history records showed that there were no issues during the manufacture of the product that 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.

• Brand Name: HANDLE FOR 90° SCREWDRIVER
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7991997
• MDR Text Key: 124678183
• Report Number: 2939274-2018-54523
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10887587013305
• UDI-Public: (01)10887587013305
• Combination Product (y/n): N
• PMA/PMN Number: K082649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

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: 03.505.004
• Device Catalogue Number: 03.505.004
• Device Lot Number: 8165482
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/05/2018
• Initial Date FDA Received: 10/22/2018
• Supplement Dates Manufacturer Received: 11/01/2018
• Supplement Dates FDA Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1