MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; WIRE, SURGICAL

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

510k: this report is for an unknown k-wire/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes sales consultant.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 that on (b)(6) 2019, during an unknown procedure, the k-wire that was used for the cannulated screw broken.The very tip of the k-wire remained in the patient.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.Concomitant device reported: cannulated screw (part/lot unknown, quantity 1).This report is for an unknown k-wire.This is report 1 of 1 for (b)(4).

• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8672186
• MDR Text Key: 147461808
• Report Number: 2939274-2019-58494
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/07/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 06/05/2019
• 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