MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/125 DEG TI CANN TFNA 170MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.037.112S

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.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.

Event Description

It was reported on (b)(6) 2020 that the facility received products that were damaged during shipping.It was reported that there was liquid in the packing for one (1) ti cannulated tibial nail and one (1) 11mm/125 deg ti cann tfna 170mm - sterile.There was no patient involvement.This report is for one (1) 11mm/125 deg ti cann tfna 170mm - sterile.This is report 2 of 2 for (b)(4).

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.H3, h4, h6: part #: 04.037.112s, synthes lot number: 53p3882, supplier lot #: 53p3882, expiration date: march 31, 2030, release to warehouse date: april 16, 2020, supplier: (b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the 11mm/125 deg ti cann tfna 170mm - sterile (product code: 04.037.112s & lot no: 53p3882) packaging was received unopened at us customer quality (cq).Upon visual inspection, a liquid spill was observed on the outer packaging (box) surface.The box was opened during the investigation and it was observed that sterility was not compromised as the sterility barrier for all devices was intact within the cardboard box.Thus, the overall complaint was confirmed.Document/specification review a drawing review of the device was not performed as there was only damage to the device¿s packaging.Complaint confirmed? yes.The device package was damaged due to the liquid spill.Investigation conclusion: the overall complaint was confirmed for the received device as the outer packaging was damaged due to the liquid spill.A root cause could not be determined as the circumstances of the event were unknown; however, it is possible that the damage to the packaging occurred during shipment and handling.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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: 11MM/125 DEG TI CANN TFNA 170MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10449871
• MDR Text Key: 204258151
• Report Number: 2939274-2020-03786
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982096302
• UDI-Public: (01)10886982096302
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.037.112S
• Device Catalogue Number: 04.037.112S
• Device Lot Number: 53P3882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Date Manufacturer Received: 09/02/2020
• Patient Sequence Number: 1
• Treatment: 10MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE; 10MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE