MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE; SCREDRIVERS

Model Number 399.40

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn.Device was used for treatment, not diagnosis.

Event Description

It was reported on an unknown date, the periosteal elevator curved blade straight edge is coming apart found by sterile processing staff.There was no patient and procedure involvement.  this complaint involves one (1) device.  this report is 1 of 1 for (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.H3, h6: a product investigation was conducted.Visual inspection: the periosteal elevator 6 mm curved blade-straight edge (part 399.40, lot unknown) was returned to us customer quality.Upon visual inspection, the shaft was coming off of the phenolic handle.The shaft was still in tight fit with the handle and did not completely come off.In addition, it was noted that exposed region of the shaft had corrosion and residue deposit as result of repeated sterilization.The remained for the device appeared to be in good condition.This is consistent with the reported complaint condition, thus confirming the complaint.Document review: due to unknown lot number, all available production drawings were reviewed.Based on design change order (dco), the drawing periosteal elevator, 6mm, curved blade staright edge revision a was released in 2002.Per revision a, country of origin was no longer a requirement ¿ however, country of origin was found to be etched on the returned device.Per revision a, lot number etching was a requirement.However, no lot number etch was found to be on the returned device based on these findings, it can be said with confidence that the returned device was made to a prior revision a and that the device was manufactured prior to 2002.The drawing review for the previous revisions manufactured by supplier (b)(4) were not accessible.Hence, the drawing review could not be completed.Since a lot number was not available, device history review could not be performed.Dimensional inspection: based on visual, inspection, the complaint condition of shaft coming off of the handle was confirmed.The remained for the device appeared to be in good condition.It appears that the device functioned as intended for the 16+ years and hence there no indication that a design or manufacturing issue contributed to the complaint.Therefore, dimensional analysis was deemed unnecessary.Conclusion: the returned device was 16+ years old.While no definitive root cause could be determined it is possible that the device underwent extensive wear and repeated sterilization over an extended lifetime that could have contributed to complaint condition.There is no indication that a design or manufacturing issue contributed to the complaint.No new malfunctions were observed during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

• Brand Name: PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE
• Type of Device: SCREDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8249098
• MDR Text Key: 133225688
• Report Number: 2939274-2019-55852
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982202789
• UDI-Public: (01)10886982202789
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

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
• Device Operator: Health Professional
• Device Model Number: 399.40
• Device Catalogue Number: 399.40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 02/11/2019
• Supplement Dates FDA Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1