MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP; FORCEPS

Model Number 03.118.111

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

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.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.(b)(4).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 during on an unknown procedure (b)(6) 2019, the long thread of the headless compression screw did not engage in the near cortex.The head would not advance into the bone and was still in the joint.The surgeon removed the screw and used a non-synthes headless screw to complete the surgery.In addition, it was reported that the silicone handle broke into two pieces.Procedure was successfully completed with a surgical delay of twenty to thirty (20-30) minutes.There was no patient harm.This report is for a silicone handle/quick coupling with rotating cap.This is report 2 of 2 for (b)(4).

• Brand Name: SILICONE HANDLE/QUICK COUPLING W/ ROTATING CAP
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8760890
• MDR Text Key: 150027360
• Report Number: 2939274-2019-59028
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982073686
• UDI-Public: (01)10886982073686
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.118.111
• Device Catalogue Number: 03.118.111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 07/03/2019
• 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