MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/270MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.016.270S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.It is unknown when the event occurred.Implant date: unknown.Complainant part has not been returned for manufacturer review/investigation.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 the patient underwent a revision surgery on (b)(6) 2018 due to a broken multiloc nail and nonunion of left distal humerus.The nail was removed, the nonunion was reduced, and an extra articular distal humerus plate was applied.The surgeon opted to utilize 5 cc of vivigen bone graft to the nonunion site.The surgeon believes the construct was originally implanted a couple of months ago (by another surgeon/facility).The surgeon stated that the nail broke due to nonunion; the nail broke at the nonunion site at the most proximal of the distal locking holes.Patient had a previous nonunion and was revised with this nail.No information about first procedure or implants is available.Screws and end cap came out easily but nail took some time.Procedure completed successfully.This complaint involves 1 (one) device.Concomitant devices: end-cap (part#: 04.019.015, lot #: unk, qty: 1).Multiloc screw (part #: 04.019.044, lot #: unk, qty: 1).Locking screw (part #: 04.005.418, lot #: unk, qty: 1).This complaint is for one (1) nail.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review is pending completion.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
A device history record (dhr) review could not completed as provided part and lot number combination is unknown in our records.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: 7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/270MM-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: 7231087
• Report Number: 2939274-2018-50445
• Device Sequence Number: 1826543
• Product Code: HSB
• UDI-Device Identifier: 10886982089281
• UDI-Public: (01)10886982089281(10)59620610
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K120807
• 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
• Report Date (Section B): 01/11/2018

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 Model Number: 04.016.270S
• Device Catalogue Number: 04.016.270S
• Device Lot Number: 5920610
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2018
• Supplement Date Received by Manufacturer: 02/01/2018; 03/10/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 02/21/2018; 03/12/2018
• 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