MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED 3.5MM HEXAGONAL SCREWDRIVER; SCREWDRIVERS

Model Number	314.19
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).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 or Problem Description
It was reported that on an unknown date during sterilization, a cannulated hexagonal screwdriver was noted to be "leeching" brown onto any contact surfaces.Item was rewashed, and problem persisted.It was noted that the item was unsterile.There was no patient consequence and no patient involvement reported.This report is for one (1) cannulated 3.5mm hexagonal screwdriver.This is report 1 of 1 for (b)(4).
Additional 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.H10 additional narrative: d4; d10.H3, h4, h6: a device history record (dhr) review was conducted: part# 314.19, lot# a4hr648, manufacturing location: synthes brandywine, released to warehouse date: 06aug1998.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.H3, h6: a product investigation was conducted.Visual inspection: visual inspection of the returned device performed at customer quality (cq) identified no damage and no leeching brown substance.No visual evidence of the leeching brown substance was provided by the reporter.The received condition does not agree with the complaint description.This complaint is not confirmed.Dhr review: the returned device was manufactured in 1998 and is over 20 years old.Document/specification review: the relevant design drawings were reviewed during this investigation.Recommendations for processing synthes reusable medical devices sold in north america can be found in the document titled "processing synthes reusable medical devices - instruments, instrument trays and cases" technique guide.Also letter silicone handle" describes the transition plan/timeline for replacing phenolic style handles.The complaint device (314.19) has already been converted to silicone handle via design change.No product design issues or discrepancies were observed during this investigation.Investigation conclusion: a definitive assignable root cause for the reported condition of leeching brown substance could not be determined based on the provided information.This complaint was not able to be confirmed and no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.Recommendations for processing synthes reusable medical devices sold in north america can be found in the document titled "processing synthes reusable medical devices - instruments, instrument trays and cases" technique guide.Also letter silicone handle" describes the transition plan/timeline for replacing phenolic style handles.The complaint device has already been converted to silicone handle via design change.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H11 corrected data, g1: physical manufacturer, 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: CANNULATED 3.5MM HEXAGONAL SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8205897
• Report Number: 2939274-2018-55640
• Device Sequence Number: 1961331
• Product Code: HXX
• UDI-Device Identifier: 10886982188663
• UDI-Public: (01)10886982188663
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2018

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
• Operator of Device: Health Professional
• Device Model Number: 314.19
• Device Catalogue Number: 314.19
• Device Lot Number: A4HR648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 12/31/2018
• Supplement Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1