MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 1.0MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/75MM; BIT,DRILL

Catalog Number	03.130.100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device is an instrument and is not implanted/explanted.Date returned to manufacturer.Without a lot number the device history records review could not be completed.Subject device has been received and is currently in the evaluation process.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 the patient had original surgery on (b)(6) 2017 for treatment of a third metacarpal fracture.Inter-operative, as the surgeon was drilling a pilot hole thru the 1.3mm locking t -plate, the tip of the 1.0mm drill bit broke off and became embedded in the patient¿s metacarpal bone.Surgeon then attempted to implant a 1.3mm locking screw but the screw head broke off due to the distal portion of the screw met the tip of the previously embedded drill bit.The distal portion of the 1.3mm locking screw remains in the patient¿s metacarpal bone.Surgeon then attempted to drill another pilot hole, thru another screw hole position, on the locking t-plate plate by using another 1.0mm drill bit.Again, the tip of this 1.0mm drill bit broke off and became imbedded in the patient¿s metacarpal bone.Moving forwarded on the procedure, surgeon decided to remove the locking t-plate.Surgeon selected a 12-hole locking plate and screws to compress the fracture.Upon completing this procedure, the patient was ultimately implanted with one (1) 1.3mm locking 12-hole straight hole plate and a combination length of six (6) 1.3mm cortex stardrive screws.Additional x-rays were taken to verify placement of fragments.Surgery was completed successfully with a five (5) minute time delay.Patient is reported in stable condition.Subsequently, part of one of the broken 1.0mm drill bits became lodged inside the 1.3/1.0mm double drill sleeve instrument.Concomitant devices reported: 1.3mm locking screws (part number unknown, lot number unknown, quantity 6), 1.3mm locking straight plate 12 holes (02.130.151, lot number unknown, quantity 1), 1.3mm locking t-plate (02.130.152, lot number unknown, quantity 1) this report is for one (1) 1.0mm drill bit this is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Subject device has been received and is currently in the evaluation process.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.
Additional Manufacturer Narrative
Product development investigation was completed.A small fragment of the drill bit was found to be embedded in the returned drill sleeve (03.130.125).The fragment was unable to be removed, as such no dimensional evaluation, material or hardness testing was able to be completed.Whether the complaint condition was able to be replicated is not applicable.Relevant drawings for the returned device were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of this device.No device history review is possible as the device lot number is unknown.As per the technique guide, the 1.0mm drill bit, k-wire attachment, for threaded hole, 75mm (03.130.100) is a component of the variable angle locking hand system which is indicated for fraction fixation of the hand and other small bones and small bone fragments.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.

• Brand Name: 1.0MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/75MM
• 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: 7185843
• Report Number: 2939274-2018-50199
• Device Sequence Number: 1786549
• Product Code: HTW
• UDI-Device Identifier: 10886982075215
• UDI-Public: (01)10886982075215(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.130.100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Initial Date Received by Manufacturer: 12/15/2017
• Supplement Date Received by Manufacturer: 02/07/2018; 02/08/2018
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 02/07/2018; 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR