MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BALL HEX SCREWDRIVER 8MM; SCREWDRIVERS

Catalog Number	03.010.092
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is synthes sales consultant.Patient code no code available used to capture no patient involvement without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that four (4) ball hex screwdriver 8mm and four (4) stardrive screwdriver t25/self retaining have a greasy substance on the underside of the instruments.All eight (8) instruments are from two (2) different sterile trays of ex retrograde antegrade femoral nail instruments and two (2) different sterile trays of ex tibial nail instruments.Instruments have been removed from circulation.No patient involvement was reported.This report is for one (1) ball hex screwdriver 8mm.This is report 1 of 8 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.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.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.
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.H3, h4, h6: dhr review was completed.Part no.: 03.010.092, lot no.: l029470, manufacturing location: haegendorf, release to warehouse date: 18.Aug.2016, no 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: customer quality conducted an investigation of the returned device.The ball hexagonal screwdriver, 8mm (03.010.092) is noted in multiple system technique guides including: titanium cannulated adolescent lateral entry femoral nail expert nailing, titanium cannulated laterial entry femoral nail and titainium cannulated tibial nail ¿ expert.In each instance the device is available to assemble the insertion construct including attaching the connecting screw to the nail and mounting the aiming arm.The following investigation flow was performed: visual ("appearance" not as expected).The returned device was examined and the complaint condition was unable to be confirmed as no coating was noted on the device¿s handle upon receipt.Whether or not the complaint condition as able to be replicated is not applicable.The device was sterilized prior to receipt which appears to have removed the substance.Relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture): top-level.The design, materials and finishing processes were found to be appropriate for the intended use of this device.A device history review, including material and hardness reviews, was performed for the returned instrument¿s lot number and no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.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: BALL HEX SCREWDRIVER 8MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7384756
• Report Number: 2939274-2018-51341
• Device Sequence Number: 1121714
• Product Code: HXX
• UDI-Device Identifier: 10886982067630
• UDI-Public: (01)10886982067630(10)LOTUNKNOWN
• 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,Followup
• Report Date (Section B): 03/02/2018

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 Catalogue Number: 03.010.092
• Device Lot Number: L029470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 05/02/2018; 05/24/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 05/22/2018; 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1