MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM TI MULTILOC SCREW LENGTH 42MM; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.005.456

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional product code hwc.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 that on (b)(6) 2020, the patient underwent a revision procedure and removal of the multi lock femoral nail.The implant removal was due to the quality of implants and non-union.Initially, patient had a zimmer biomet proximal humerus plate that was revised to synthes multiloc humeral nail due to zimmer plate failure.It was also mentioned that the patient had an infection prior to surgical implant that ultimately led to the non-union.During the procedure, the femoral implant was removed ahead proximal nail to get the proximal screw still intact.The patient was then revised to a reverse shoulder.The procedure was successfully completed.It is unknown if there was a surgical delay.Patient status is unknown.This complaint involves eight (8) devices.This report is for (1) 4.0mm ti locking screw w/t25 stardrive 66mm for im nails.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.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: 4.5MM TI MULTILOC SCREW LENGTH 42MM
• 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: 10810318
• MDR Text Key: 215330926
• Report Number: 2939274-2020-05029
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982085689
• UDI-Public: (01)10886982085689
• Combination Product (y/n): N
• PMA/PMN Number: K103002
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.005.456
• Device Catalogue Number: 04.019.042
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2020
• Patient Sequence Number: 1
• Treatment: 3.5MM TI LCKNG SCR SLF-TPNG W/ STRDR RCES 42MM; 3.5MM TI LCKNG SCR SLF-TPNG W/ STRDRV RCES 40MM; 4.0MM TI LCKNG SCRW W/T25 STRDRV 26MM FR IM NALS; 4.0MM TI LCKNG SCRW W/T25 STRDRV 30MM FR IM NALS; 8.5MM TI MLTC HMRL NAL LFT/CANN/225MM-STRLE; 3.5MM TI LCKNG SCR SLF-TPNG W/ STRDR RCES 42MM; 3.5MM TI LCKNG SCR SLF-TPNG W/ STRDRV RCES 40MM; 4.0MM TI LCKNG SCRW W/T25 STRDRV 26MM FR IM NALS; 4.0MM TI LCKNG SCRW W/T25 STRDRV 30MM FR IM NALS; 8.5MM TI MLTC HMRL NAL LFT/CANN/225MM-STRLE
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR