MAUDE Adverse Event Report: 1303 GOSHEN SYNTHES USA PRODUCTS LLC 8.5 TI MULTILOC HUM NL LFT/CANN/300-S; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.019.300S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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, patient underwent revision surgery due to nonunion.The patient had sustained an open humerus fracture that was temporarily put in an external fixator and eventually nailed with multiloc nail.The screws through the nail had quite a bit of bony overgrowth which made them difficult to remove.They are all successfully removed intact, and the nail was removed successfully.The nonunion fracture was then fixated with an extra-articular distal humerus plate along with a 3.5 lcp plate.This report is for one (1) 8.5mm ti multiloc humeral nail left/cann/300mm-sterile.This is report 1 of 6 for complaint (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.H6: part: 04.019.300s, lot: l171258, manufacturing site: mezzovico, release to warehouse date: 28 dec 2016, expiry date: 01 dec 2026.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Photo investigation: the device was not returned.A photo-investigation was performed on the x-ray.Since the x-ray shows the plate with all 5 screws still intact, the complaint condition cannot be confirmed.Additionally, the root cause of the issue cannot be determined based on the available information.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition cannot be confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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.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: 8.5 TI MULTILOC HUM NL LFT/CANN/300-S
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): 1303 GOSHEN SYNTHES USA PRODUCTS LLC; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 11848674
• Report Number: 2530088-2021-00001
• Device Sequence Number: 11773122
• Product Code: HSB
• UDI-Device Identifier: 10886982090126
• UDI-Public: (01)10886982090126
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120807
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.019.300S
• Device Catalogue Number: 04.019.300S
• Device Lot Number: L171258
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/10/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAIL HEAD ELEMENTS: MULTILOC HUMERAL SCREW; UNK - NAIL HEAD ELEMENTS: MULTILOC HUMERAL SCREW; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 100