MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE; SCRWEDRIVERS

Model Number 314.02

Device Problems Use of Device Problem (1670); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review / investigation, but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 on (b)(6) 2019, after sterilization, it was noticed that the following wood handle screwdrivers had a leaking dye; one (1) cruciform screwdriver with holding sleeve, ten (10) small hexagonal screwdriver with holding sleeve, one (1) large screwdriver, one (1) cannulated hexagonal screwdriver, and five (5) stardrive screwdriver.All these wood handle screwdrivers are leaking dye into the trays as they have been through countless sterilizations and been in circulation for many years.There was no patient involvement.This complaint involves ten (10) devices.This report is for one (1) small hexagonal screwdriver with holding sleeve.This report is 9 of 10 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.H10 additional narrative: h3, h4, h6: the small hexagonal screwdriver with holding sleeve (p/n 314.02 lot unk) was received showing the phenolic le grade handle discolored and worn, consistent with repeated reprocessing cycles over the part¿s lifetime and normal wear.The hex driver tip was also stripped and rounded.No evidence of leaking dye was observed on the device or handle, therefore, the reported complaint is not confirmed.The discolored handle and stripped driver tip are potential end of life indicators for the instrument from normal wear and reprocessing over the part¿s lifetime.A dhr review for the manufacturing records and the material records could not be performed as the lot number is unknown and there is no lot number specified in design drawing.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.After a visual inspection it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE
• Type of Device: SCRWEDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8923485
• MDR Text Key: 163751496
• Report Number: 2939274-2019-60008
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982188373
• UDI-Public: (01)10886982188373
• 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: 07/25/2019

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: 314.02
• Device Catalogue Number: 314.02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/22/2019
• Supplement Dates Manufacturer Received: 09/04/2019
• Supplement Dates FDA Received: 09/19/2019
• Patient Sequence Number: 1