MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6MM/9MM CANNULATED STEPPED DRILL BIT; BIT, DRILL

Model Number 03.037.022

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

Part number: 03.037.022, lot number: f-24978, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: 31.July 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) was reviewed, and the complaint condition could be confirmed since the tip of the blade was clearly broken into 2+ pieces.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that during the surgical procedure, the tip of the drill bit was damaged.Another set was open to complete the case.The procedure was completed successfully and no known adverse effects were reported.This report is for one (1) 6mm/9mm cannulated stepped 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 completed: upon visual inspection, it was observed that the distal tip of the device was broken, and the broken portion was not returned.No other issues were identified with the returned device.The relevant dimensions were reviewed and found to be conforming.Based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed.The device received was broken.Hence confirming the allegation.There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H11: corrected data: b4/g4: awareness date initially reported as august 28, 2020 but should have been august 27, 2020.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: 6MM/9MM CANNULATED STEPPED DRILL BIT
• 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: 10433008
• MDR Text Key: 204258642
• Report Number: 2939274-2020-03694
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10886982070388
• UDI-Public: 10886982070388
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.022
• Device Catalogue Number: 03.037.022
• Device Lot Number: F-24978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1