MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 390MM-STERILE; NAIL, FIXATION, BONE

Model Number	04.034.458S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: this information is unknown.Date of event is unknown.Implantation date is unknown.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.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 a revision surgery was performed on (b)(6) 2018 for a distal third tibia fracture due to the loss of fixation and nail/screw breakage.The tibial nail broke at the proximal distal locking hole and one broken screw, location unknown.The broken nail was removed and a new nail was implanted; the broken screw was left in the patient.There was no delay in surgery, no unanticipated x-rays taken and no additional medical intervention.Fragments were generated (one of the broken screws from the original surgery was left in the tibia).There were no clinical findings.Procedure was completed successfully.Patient outcome is unknown.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was performed: manufacturing location: (b)(4), manufacturing date: 21-aug-2017, expiration date: 31-jul-2026: par no: 04.034.437s, lot # h431423 (sterile) - 10mm titanium (ti) cannulated tibial nail - ex w/prox bend 285mm-sterile.Quantity 6.Raw material part 21012, lot no: h387300 was received from supplier perryman company.Certificate of test received from perryman company for titanium meet specification.Raw material receiving/putaway checklist meet requirements.Inspection sheet for in-process acceptance, inspectional dimension & final inspection meets inspection acceptance criteria.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.
Additional Manufacturer Narrative
Concomitant devices reported.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
Concomitant device reported: distal locking screw (partial part number 04.005.Xxx, lot number unknown, quantity 1).
Additional Manufacturer Narrative
Corrected data: part 04.304.458s and lot h431423 is not a valid part/lot combination.Expiration date and date of manufacture is not known.Dhr review was attempted.Part number: 04.304.458s.Synthes lot number: h431423.Supplier lot number: n/a.Release to warehouse date: unknown.Review of the device history record(s) could not be performed as dhr records show that lot number h431423 corresponds to part number 04.034.437s and part number 04.034.458s corresponds to similar lot numbers h431420, h431422, h431424, and h431426 only.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.
Additional Manufacturer Narrative
Corrected data: part 04.034.458s and lot h431423 is not a valid part/lot combination.Expiration date and date of manufacture is not known.Dhr review was attempted.Part number: 04.034.458s.Synthes lot number: h431423.Supplier lot number: n/a.Release to warehouse date: unknown.Review of the device history record(s) could not be performed as dhr records show that lot number h431423 corresponds to part number 04.034.437s and part number 04.034.458s corresponds to similar lot numbers h431420, h431422, h431424, and h431426 only.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: 10MM 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: 7458708
• Report Number: 2939274-2018-51912
• Device Sequence Number: 16430915
• Product Code: JDS
• UDI-Device Identifier: 10886982095275
• UDI-Public: (01)10886982095275
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/05/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: 04.034.458S
• Device Catalogue Number: 04.034.458S
• Device Lot Number: H431423
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 04/27/2018; 06/04/2018; 06/05/2018; 06/05/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 05/15/2018; 06/04/2018; 06/05/2018; 06/05/2018
• 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: 56 YR