MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM TI CANNULATED TIBIAL NAIL-EX/330MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.004.546S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted: device history lot: manufacturing location: (b)(4), manufacturing date: jan 15, 2020, expiration date: dec 31, 2028, part number: 04.004.546s, 11mm ti cannulated tibial nail ¿ ex/330mm-sterile, lot number: 34p7968 (sterile), lot quantity: 6.Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process/inspect dimensional/final, ns072581 rev a met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 17111 supplied by (b)(4) (abq) was reviewed and determined to be conforming.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.Component parts reviewed: part number: 21012, tialnbri13.00, lot number: 11l041, lot quantity: 3,613 lbs.Inspection instruction met all inspection acceptance criteria.Certified test report supplied by (b)(4) company dated jun 21, 2019 and certificate of test supplied to (b)(4) by (b)(4) dated jul 25, 2018 were reviewed and determined to be conforming.Lot summary report dated jun 24, 2019 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history review: 07-jul-2020: dhr reviewed.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, during drilling for proximal unknown screws, the drill bit was contacted nail and with an unknown issue.The surgeon successfully passed the unknown screw and after the surgery, the guide/ drill sleeve lined up.It is unknown if there was a surgical delay.The procedure was successfully completed.The patient outcome was unknown.This complaint involves six (6) devices.This report is for (1) insertion handle for suprapatellar.This is report 6 of 6 for (b)(4).

• Brand Name: 11MM TI CANNULATED TIBIAL NAIL-EX/330MM-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: 10286007
• Report Number: 2939274-2020-03237
• Device Sequence Number: 13602291
• Product Code: JDS
• UDI-Device Identifier: 10886982084477
• UDI-Public: (01)10886982084477
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2020

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: 04.004.546S
• Device Catalogue Number: 04.004.546S
• Device Lot Number: 34P7968
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 07/16/2020
• Patient Sequence Number: 1
• Patient Age: 51 YR