MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8MM TI MULTILOC PROX HUMERAL NAIL/RIGHT/CANN/160MM-STER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.016.034S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.
Event or Problem Description
It was reported that on (b)(6) 2021, the patient underwent hardware removal.The doctor was removing a broken multiloc nail.The nail broke above the proximal locking hole.The nonunion was repaired with plates and screws construct.There was a surgical delay of fifteen (15) minutes.The procedure was successfully completed, and the patient outcome was good.This report involves one (1) 8mm ti multiloc prox humeral nail/right/cann/160mm-ster.This is report 1 of 1 for (b)(4).The product complaint, (b)(4), is related to (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: part # 04.016.034s.Lot # l318484.Release to warehouse date: july 12, 2017.Manufacturer: mezzovico.No ncr's were generated during production.Visual inspection: multiloc phn ø8 r cann l160 tan (p/n: 04.016.034s, lot #: l318484) was returned and received at us customer quality cq.Upon visual inspection, the distal end of the humerus nail was observed to be broken.Additionally, scratches and discoloration were observed on the device which could have potentially been caused during the explantation process.Device failure/defect identified? yes.Dimensional inspection: dimensional inspection could not be performed due to the post-manufacturing damage.Document/specification review: the following documents were reviewed: multiloc phn right ø8,ø9.5 asm: manufactured and current revisions complaint confirmed? yes.Investigation conclusion the complaint condition could be confirmed for the returned device.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 8MM TI MULTILOC PROX HUMERAL NAIL/RIGHT/CANN/160MM-STER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12019035
• Report Number: 2939274-2021-03026
• Device Sequence Number: 19921832
• Product Code: HSB
• UDI-Device Identifier: 10886982089182
• UDI-Public: (01)10886982089182
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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: 04.016.034S
• Device Catalogue Number: 04.016.034S
• Device Lot Number: L318484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/16/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - END CAPS: MULTILOC HUMERAL NAIL; UNK - SCREWDRIVERS; UNK - SCREWS: HUMERAL NAIL; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention