MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7.3MM CANNULATED LOCKING SCREW 85MM; SCREW,FIXATION,BONE

Model Number 02.207.085

Device Problem Break (1069)

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: additional product code: hty jdw hrs.Complainant part is not expected to be returned for manufacturer review/ investigation.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 Description

It was reported that on (b)(6) 2021, the 4.5mm lcp proximal femur plate with broken 7.3mm cannulated locking screws loss of reduction.The date and location of the original fixation are unknown.Hardware was removed by the surgeon on thursday, (b)(6) 2021.The procedure outcome is unknown.There was no patient consequence.Concomitant device reported: unk - screws: locking: (part# unknown; lot# unknown; quantity: unknown).This complaint involves two (2) devices.This report is for (1) 7.3mm cannulated locking screw 85mm.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: additional product code: hty jdw hrs.Complainant part is not expected to be returned for manufacturer review/ investigation.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 Description

It was reported that on (b)(6) 2021, the 4.5mm lcp proximal femur plate with broken 7.3mm cannulated locking screws loss of reduction.The date and location of the original fixation are unknown.Hardware was removed by the surgeon on thursday, (b)(6) 2021.The procedure outcome is unknown.There was no patient consequence.Concomitant device reported: unk - screws: locking: (part# unknown; lot# unknown; quantity: unknown).This complaint involves two (2) devices.This report is for (1) 7.3mm cannulated locking screw 85mm.This report is 2 of 2 for (b)(4).

• Brand Name: 7.3MM CANNULATED LOCKING SCREW 85MM
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13119751
• MDR Text Key: 286131342
• Report Number: 2939274-2021-07300
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982051868
• UDI-Public: (01)10886982051868
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.207.085
• Device Catalogue Number: 02.207.085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 4.5 LCP PROXIMAL FEMUR PL 14 H/355-LFT; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Sex: Male