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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot manufacturing location: (b)(4), manufacturing date: 17-apr-2020, expiration date: 31-mar-2029, part number: 04.004.555s, 11mm ti cannulated tibial nail ¿ ex/375mm-sterile, lot number: 52p3107 (sterile).Component part(s) reviewed: part number: 21012, tialnbri13.00, lot number: 13l9337.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture 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.
Event or Problem Description
It was reported that on (b)(6) 2020, during an unknown procedure, while drilling, the surgeon hit the nail and devices (insertion handle, cannulated screw, protection sleeve, drill sleeve, aiming arm for supratellar, titanium cannulated tibial nail, and drill bit) did not line up completely.The procedure was successfully completed with no surgical delay.No patient consequences.This complaint involves seven (7) devices.This is report 6 of 7 for (b)(4).
Event or Problem Description
Concomitant devices reported: nail (part unknown, lot unknown, quantity 1).
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: b5 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: 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: 11078237
• Report Number: 2939274-2020-05728
• Device Sequence Number: 19576909
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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: 04.004.555S
• Device Catalogue Number: 04.004.555S
• Device Lot Number: 52P3107
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 01/19/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12.0MM/8.0MM PROTECTION SLEEVE 188MM; 8.0MM/4.2MM DRILL SLEEVE 200MM; AIMING ARM FOR SUPRAPATELLAR; INSERTION HANDLE FOR SUPRAPATELLAR; UNK - NAILS; 12.0MM/8.0MM PROTECTION SLEEVE 188MM; 8.0MM/4.2MM DRILL SLEEVE 200MM; AIMING ARM FOR SUPRAPATELLAR; INSERTION HANDLE FOR SUPRAPATELLAR
• Patient Age: 29 YR