MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 390MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.034.558S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.This mre review is for sterilization procedure only part: 04.034.588s, lot: 7488853, manufacturing site: (b)(4), supplier: (b)(6), release to warehouse date: 16.October 2013, expiry date: 01.October 2023.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile 04.034.588 / 7488601 was manufactured in us, (b)(4).Manufacturing location: (b)(4), manufacturing date: 24-sep-2013, part number: 04.034.558, 11mm ti cann tibial nail - ex w/prox bend 390mm, lot number: 7488601 (non-sterile), lot quantity: (b)(4), work order traveler 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 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.Component part(s) reviewed: raw material was not reviewed because the reported complaint condition of ¿removal due to possible infection¿ does not indicate breakage of the nail.Therefore, a dhr review of the raw material would not be pertinent to the reported complaint condition.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.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 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) 2019 the patient underwent a hardware removal of one (1) tibial nail and four (4) locking screws.A reamer irrigator aspirator (ria) was done due to possible infection.It appeared that the fracture was healed.It is unknown if there was a surgical delay.The procedure outcome was unknown.There was no patient consequences reported.This report is for one (1) 11mm ti cann tibial nail-ex w/prox bend 390mm-sterile.This is report 1 of 5 for (b)(4).

• Brand Name: 11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 390MM-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: 9445024
• Report Number: 2939274-2019-62613
• Device Sequence Number: 14013828
• Product Code: JDS
• UDI-Device Identifier: 10886982095404
• UDI-Public: (01)10886982095404
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: 04.034.558S
• Device Catalogue Number: 04.034.558S
• Device Lot Number: 7488853
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/10/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention