MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.8MM DRILL BIT/QC/165MM; BIT, DRILL

Model Number 310.288

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Occupation: reporter is a synthes employee.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this 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

It was reported that on (b)(6) 2019, the drill bit had an unfinished, black blemish.This was discovered in the receiving area.There was no patient involvement.This report is for a 2.8mm drill bit.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: a product investigation was conducted.Visual inspection: the received condition of the complaint does agree with the complaint description since the returned device has an unfinished black blemish in a way which could lead to the complaint condition.The complaint condition is confirmed.Dimensional inspection: dimensional inspection was not performed because it is not relevant to the condition of unfinished black blemish.Document/ specification review: a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation conclusion: manufacturing investigation: the received condition of the complaint does agree with the complaint description since the returned device has an unfinished black blemish in a way which could lead to the complaint condition.Therefore, this complaint is rated as confirmed.Besides, from the manufacturing point of view, this complaint is rated as valid since the report ¿mat3842_en.Pdf¿ state that the color on the drill bit¿s flute has the same chemical composition as the color at the coupling end.Therefore, additional investigations will be conducted through the nr.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: part: 310.288, lot: 4l52812, manufacturing site: bettlach, release to warehouse date: 15.May 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 2.8MM DRILL BIT/QC/165MM
• 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: 8864818
• MDR Text Key: 153414704
• Report Number: 2939274-2019-59532
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10886982186423
• UDI-Public: (01)10886982186423
• 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
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 310.288
• Device Catalogue Number: 310.288
• Device Lot Number: 4L52812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1