MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8MM TI CANN TIBIAL NAIL-EX W/PROX BEND 270MM-STERILE; NAIL, FIXATION, BONE

Model Number	04.034.234S
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight is unknown.Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.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 on (b)(6) 2018, the surgeon could not disengage the cannulated connecting screw from the implanted titanium cannulated tibial nail.Surgeon was able to use a screwdriver and open end wrench to remove the connecting screw.There was a five (5) minute surgical delay.Procedure was completed successfully with no patient consequence.This complaint is for a 8mm ti cann tibial nail-ex w/prox bend 270mm.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
A device history record review was performed for the subject device: please note, this dhr review is for sterilization procedure only: part no.: 04.034.234s, lot no.: 7142064, manufacturing location: selzach supplier: (b)(4), release to warehouse date: 10.Jan.2013 , expiry date: 25.Dec.2021.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Non-sterile 04.034.234 / 7142064 was manufactured in us, monument.Manufacturing location: (b)(4), packaged by: monument manufacturing date: 18-dec-2012 part #: 04.034.234, lot#: 7142064 (non-sterile) - 8mm ti cann tibial nail-ex w/prox bend 270mm.Qty: 6.Components: raw material part 21012, lot: 6839555.Raw material supplied from dynamet incorporated.Dynamet certificate of compliance meet specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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: 8MM TI CANN TIBIAL NAIL-EX W/PROX BEND 270MM-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: 7508552
• Report Number: 2939274-2018-52142
• Device Sequence Number: 19138628
• Product Code: JDS
• UDI-Device Identifier: 10886982094933
• UDI-Public: (01)10886982094933
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2018

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: 12/25/2021
• Device Model Number: 04.034.234S
• Device Catalogue Number: 04.034.234S
• Device Lot Number: 7142064
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR