MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/195MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.019.195S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Based on the information available, it has been determined that no corrective and 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 an unknown date, the patient underwent for a surgery.During the surgery, the multiloc humeral nail was hitting the nail, the cable lock for cable tensioner did not lock while pistol gripping, and the parallel wire guide didn¿t need feed wire through was bent.There were four minutes surgical delay.The procedure outcome was unknown.There was no patient consequence reported.This complaint involves five (5) devices.This report is for (1) 8.5mm ti multiloc humeral nail left/cann/195mm-sterile.This report is 1 of 3 for (b)(4).

• Brand Name: 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/195MM-STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13170796
• Report Number: 8030965-2022-00098
• Device Sequence Number: 19973823
• Product Code: HSB
• UDI-Device Identifier: 10886982090058
• UDI-Public: (01)10886982090058
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K120807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.019.195S
• Device Catalogue Number: 04.019.195S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1.0 CABLE LCK PIST GRIP CBL TENSIONER; 1.25MM PARALLEL WIRE GUIDE; 1.25MM PARALLEL WIRE GUIDE
• Patient Sex: Unknown