MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.3MM DRILL BIT/K-WIRE ATTCHMT FOR GLIDING HOLE/60MM; BIT,DRILL

Model Number	03.130.110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number, the device history records review could not be completed as no product was received.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 or Problem Description
It was reported that on an unknown date during an open reduction internal fixation (orif) of the finger procedure on (b)(6) 2019, the drill bit of the variable angle (va) locking hand system broke inside the drill guide.The procedure was completed successfully by using the threaded drill guide and a new drill bit.The generated fragments were removed easily without additional intervention.There was no patient consequence reported.Concomitant device reported: drill guide ( part# 03.130.125, lot# unknown, quantity 1).This is report 1 of 1 for (b)(4).
Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: visual inspection: the 1.3 mm drill bit/k-wire attachment for gliding hole/60 mm (p/n: 03.130.110, lot #: unk) was broken and the broken fragment was stuck inside the drill guide.No other components of the drill bit were returned to us customer quality (cq).Device failure/defect identified? yes.Dimensional inspection: a dimensional inspection was not performed as the drill bit broke inside the guide and was inaccessible without the destruction of the drill guide.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed drill bit dia 1.0-2.0 mm.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion the complaint condition is confirmed for the 1.3 mm drill bit/k-wire attachment for gliding hole/60 mm (p/n: 03.130.110, lot #: unk).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.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.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: 1.3MM DRILL BIT/K-WIRE ATTCHMT FOR GLIDING HOLE/60MM
• Common Device Name: BIT,DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9539437
• Report Number: 2939274-2020-00014
• Device Sequence Number: 14047279
• Product Code: HTW
• UDI-Device Identifier: 10886982075246
• UDI-Public: (01)10886982075246
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019

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
• Operator of Device: Health Professional
• Device Model Number: 03.130.110
• Device Catalogue Number: 03.130.110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2019
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1