MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DPS HAERTOE CCI STD KIT 1.25 K-WIRE/ -S; STAPLE, FIXATION, BONE

Model Number Standard

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that, during a procedure the standard hammertoe did not fit into the drilled holes.The large hammertoe fit's perfectly.Procedure was successfully completed with a ten(10) minutes of surgical delay.No patient consequences.This report is for one (1) dps haertoe cci std kit 1.25 k-wire/ -s.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received.Reporter is a j&j sales representative.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.

• Brand Name: DPS HAERTOE CCI STD KIT 1.25 K-WIRE/ -S
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13515170
• MDR Text Key: 285772913
• Report Number: 2939274-2022-00429
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633022047
• UDI-Public: (01)00810633022047
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Standard
• Device Catalogue Number: 46.239.001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• 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