MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 11MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.013.556S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient date of birth not available.Date of event unknown.Original implant date unknown.Device is not expected to return for investigation.Device history review in progress.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient was implanted with one (1) retrograde femoral nail and four (4) 5.0mm locking screws on an unknown date.On (b)(6) 2017, the patient was returned to the operating room where the implants were all removed intact after a possible infection was identified.A reamer irrigator aspirator (ria) was used to wash out the canal and the patient was revised to a temporary antibiotic nail and screws.After removing the ria, it was identified that the tip of the ria drive shaft had broken off where the device connects to the reamer head.There was a reported one minute surgical delay while the surgeon confirmed that no fragments were left behind.The procedure was completed successfully and the patient was reported in stable condition.This complaint will capture the revision surgery due to reported infection, (b)(6)will capture the intraoperative breakage of the drive shaft.This is report 1 of 2 for (b)(6).
Additional Manufacturer Narrative
(b)(6).Additional product code: hwc (b)(4).(b)(6).Dhr review was completed.Manufacturing location: (b)(4) manufacturing date: 17-aug-2016 expiration date: 31-jul-2025 part #: 04.013.556s, lot#: h167519 (sterile) - 11mm ti cannulated retro/antegrade femoral nail-ex/380mm - sterile.Quantity 6.Component parts reviewed: part 21012 - raw material lot - 9958922.Raw material for (b)(4)was received from (b)(4).Certificate of test report received from (b)(4) for (b)(4) meet specification.Raw material receiving/putaway checklist meet requirements.Inspection sheet for in-process/inspect dimensional/final met inspection acceptance criteria.Inspection sheet for inspect dimensional meet specification.(b)(4) was initiated at operation 170 (boxing).This is a planned non-conformance.(b)(4) was initiated at operation gundrill and bend radius for jbs related issue.It is non-product nr and is not relevant to complaint condition of ¿ria drive shaft had broken off where the device connects to the reamer head.¿ 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.¿sterility documentation was reviewed and determined to be conforming.¿ 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 CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7155235
• Report Number: 2939274-2017-50499
• Device Sequence Number: 10787171
• Product Code: HSB
• UDI-Device Identifier: 10886982088055
• UDI-Public: (01)10886982088055(17)EXPIRATIONUNKNOWN(10)H167519
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: 04.013.556S
• Device Catalogue Number: 04.013.556S
• Device Lot Number: H167519
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 01/29/2018
• 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: 32 YR
• Patient Weight: 162