MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5MM DEPTH GAUGE 0 TO 60MM

Model Number 03.133.080

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 that, the auxiliary tray and graphic case were damaged and peeling.There was an unknown malfunction with depth gauge.It was unknown when the issue was discovered.This report is for one (1) 2.7/3.5mm depth gauge 0 to 60mm.This is report 1 of 1 for complaint (b)(4).

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.H3, h6: a product investigation was conducted.Visual inspection: the 2.7/3.5mm depth gauge 0 to 60mm (p/n: 03.133.080, lot #: j000807) was returned and received at us cq.Upon visual inspection, it was observed that the needle component was bent and clear signs of misuse were observed on the needle tip as weld marks were identified on the tip of the needle component.Additionally scratches from field usage were observed on the device.No other issues were identified.Dimensional inspection: dimensional analysis cannot be performed due to post-manufacturing damage.Document/specification review: the relevant documents were reviewed.No design issues or discrepancies were identified.Investigation conclusion: the complaint condition was confirmed for the returned device as the tip of the needle was observed to be bent and misused post-manufacturing.No definitive root cause could be determined based on the provided information.The unintended external forces might have contributed to the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.H3, h4, h6: a device history record (dhr) review was conducted: part # 03.133.080; synthes lot # j000807; supplier lot # j000807; release to warehouse date: 23 nov 2020; 08 feb 2021; supplier: (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 the tip of the depth gauge was burned and misshapen.The malfunction was discovered during inspection after the case at the tampa metro office.

• Brand Name: 2.7/3.5MM DEPTH GAUGE 0 TO 60MM
• Type of Device: 2.7/3.5MM DEPTH GAUGE 0 TO 60MM
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11896275
• MDR Text Key: 266917498
• Report Number: 2939274-2021-02648
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982269690
• UDI-Public: (01)10886982269690
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.133.080
• Device Catalogue Number: 03.133.080
• Device Lot Number: J000807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AUXILIARY TRAY/2/3 LNTH 1/2 WDTH/MOD GC; GRAPHIC CASE/2/3 LNTH 4 BAY F/MOD GC SYS