MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COUNTERSINK FOR 1.3/1.5 AND 2.0 SCREWS; GAUGE, DEPTH

Model Number 03.130.215

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/21/2022

Event Type  Injury  

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional product code: hww.Concomitant medical products: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.Device evaluated by mfr and manufacture date: 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 on (b)(6) 2022, that they used the countersink before implanting a screw, when the top of the countersink broke off in the bone of the patient.Fragments were generated.The tip of the countersink remained in the patient¿s bone.It would be too difficult to remove the piece.He said he was not worried about leaving it.There was no surgical delay.Procedure was successfully completed.Patient consequence is unknown.This report is for one (1) countersink for 1.3/1.5 and 2.0 screws.This is report 1 of 1 for complaint (b)(4).

• Brand Name: COUNTERSINK FOR 1.3/1.5 AND 2.0 SCREWS
• Type of Device: GAUGE, DEPTH
• 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
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 15047754
• MDR Text Key: 296132418
• Report Number: 2939274-2022-02670
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982075376
• UDI-Public: (01)10886982075376
• 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: Health Professional,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: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.130.215
• Device Catalogue Number: 03.130.215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention