MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLLOW GOUGE FOR BROKEN SCREW EXPOSURE; GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number 399.68

Device Problem Break (1069)

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

Event Type  malfunction  

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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during a sterile processing it was discovered that four (4) threaded handles for percutaneous threaded drill guides are stripped and will not grab threaded drill guides, locking mechanism of two (2) trocars with handle is worn out and will not properly attach to trocar sleeves and three (3) hollow gouges are chipped/broken.No known patient involvement reported this report is for one (1) hollow gouge for broken screw exposure.This is report 9 of 9 for complaint (b)(4).

• Brand Name: HOLLOW GOUGE FOR BROKEN SCREW EXPOSURE
• Type of Device: GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: 11686808
• MDR Text Key: 248077393
• Report Number: 2939274-2021-01932
• Device Sequence Number: 1
• Product Code: GDH
• UDI-Device Identifier: 10886982203038
• UDI-Public: (01)10886982203038
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 399.68
• Device Catalogue Number: 399.68
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2021
• 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