MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM TI CANNULATED TIBIAL NAIL-EX/375MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.004.555S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Dhr review was completed.Part no.: 04.004.555s , lot no.: 7275181 , manufacturing location: (b)(4), supplier: (b)(4), release to warehouse date: 14.Mar.2013 , expiry date: 01.Mar.2023 , non-sterile 04.004.555 / 7275181 was manufactured in us, (b)(4), manufacturing location: (b)(4), manufacturing date: 25-feb-2013 lot number: 7275181 / 21-jun-2010 lot number: 6410594 , part number: 04.004.555, 11mm ti cannulated tibial nail - ex/375mm , lot number: 7275181 (non-sterile) / pulled from lot number: 6410594 (sterile) , lot quantity: 2 (7275181) / 6 (6410594).Work order travelers for both lots met all inspection acceptance criteria.Inspection sheet, in-process acceptance sheet met all inspection acceptance criteria.Inspection sheet, inspect dimensional met all inspection acceptance criteria.Inspection sheet, final inspection met all inspection acceptance criteria.Packaging label log, lppf was reviewed and was found to be conforming.Packaging label log lppf, lmd/lpf rev c was reviewed and determined to be conforming.Packaging bom for this lot was reviewed and found to be conforming with no deviations to normal packaging identified.Sterilization control number (scn) # (b)(4) supplied by (b)(4) was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 during a procedure to implant a cannulated tibial nail on (b)(6) 2018, while drilling for the cannulated connecting screw on the proximal portion of the nail, surgeon had to wiggle the drill in order to get the drill bit to pass through the nail.The aiming arm, insertion handle, drill sleeve, and protection sleeve were reported to have contributed to the alignment difficulty.No devices were broken but the nail was hit.Surgery was completed successfully with no delay.This report is for one (1) 11mm cannulated tibial nail.This is report 6 of 7 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Event : updated event information.Device was used for treatment, not diagnosis.
Event or Problem Description
Update 12/04/2018: adding the concomitant part; it was reported that there was a drill used with no allegations.Modified event description: it was reported that during a procedure to implant a cannulated tibial nail on (b)(6) 2018, while drilling for the cannulated connecting screw on the proximal portion of the nail, surgeon had to shake the drill so the drill bit to pass through the nail.The aiming arm, insertion handle, drill sleeve, and protection sleeve were reported to have contributed to the alignment difficulty.No devices were broken but the nail was hit.Surgery was completed successfully with no delay.Patient outcome is unknown.Concomitant device reported: unknown drill (part # unknown, lot # unknown, quantity 1).This complaint involves seven (7) devices.

• Brand Name: 11MM TI CANNULATED TIBIAL NAIL-EX/375MM-STERILE
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8001033
• Report Number: 2939274-2018-54576
• Device Sequence Number: 203512
• Product Code: JDS
• UDI-Device Identifier: 10886982084538
• UDI-Public: (01)10886982084538
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: 04.004.555S
• Device Catalogue Number: 04.004.555S
• Device Lot Number: 7275181
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 12/05/2018
• Patient Sequence Number: 1
• Patient Age: 52 YR