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
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j sales representative.A photo investigation was performed on the image provided.Upon analysis of the image, the handle of the screw gouge was found to be cracked.This could potentially be attributed to regular usage of the device.In addition, the hollow shaft had signs of pitting on its surface which might be due to exposure to chemicals during usage or sterilization.A definitive root cause cannot be determined from the available information.Conclusion: the complaint against hollow gouge for broken screw can be confirmed based on the photograph provided.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed., a product investigation was conducted.Visual inspection: hollow gouge for broken screw exposure (p/n: 399.68, lot #: unk) was returned and received at us cq.Upon visual inspection, the handle of the screw gouge was found to be chipped and broken on the distal and proximal ends.The chipped/broken fragments were not returned.Additionally, the hollow shaft had signs of pitting on its surface which might be due to exposure to chemicals during usage or sterilization.Rest of the device shows scratches/normal wear consistent with the device use which would not contribute to the complaint condition.No other issues were observed with the complaint device.Dimensional inspection: complaint relevant dimensional analysis cannot be performed due to the post-manufacturing damage and design of the device.Document/specification review: since the exact manufactured date of the device was not identified, the relevant revision of drawings were reviewed: no design issues or discrepancies were identified.Based on the drawing revision and inspection of the returned device, the device was identified to be manufactured prior to 02-apr-2015.Investigation conclusion: the complaint could be confirmed for the returned device.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied on the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Part/lot (part:399.68/lot:905) combination is not valid, therefore the dhr could not be completed.If the lot number is confirmed the dhr will be revisited.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 or Problem Description
It was reported that on an unknown date, during cleaning it was discovered that the gouge for broken screw exposure cracked in handle.There was no patient involvement.During manufacturer's investigation of the returned device it was identified that the handle of the screw gouge was chipped and broken on the distal and proximal ends.The chipped/broken fragments were not returned.This report is for one (1) hollow gouge for broken screw exposure.This is report 1 of 1 for complaint (b)(4).

• Brand Name: HOLLOW GOUGE FOR BROKEN SCREW EXPOSURE
• Common Device Name: GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12451144
• Report Number: 2939274-2021-05294
• Device Sequence Number: 11646826
• Product Code: GDH
• UDI-Device Identifier: 10886982203038
• UDI-Public: (01)10886982203038
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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
• Operator of Device: Health Professional
• Device Model Number: 399.68
• Device Catalogue Number: 399.68
• Device Lot Number: 905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1