MAUDE Adverse Event Report: SYNTHES TUTTLINGEN SCREWDRIVER FOR PINS; SCREWDRIVERS

Model Number	U44-642-20
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement reported.Date of event is unknown.It was reported that the event was identified/noted on aug 08, 2017.Device is an instrument and is not implanted / explanted.The device was received and the product evaluation is in progress.No conclusion can be drawn.Device history records review has been requested and in pending completion.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 after sterilization of the anterior cervical fusion tray, the bottom of the pan had a brown residue pooled at the bottom.This made the tray contaminated and unusable in surgery.A swab test was done by the head of the sterilization department.The test came back with no traces of biologic materials.Therefore, the contaminating substance most likely came from the synthes tray.No patient involvement reported.This report is for one (1) screwdriver for pins.(b)(4).
Additional Manufacturer Narrative
Additional narrative: device history records (dhr) review was attempted for part# u44-642-20, lot# a70a15.Manufacturing date: week 15 in 2005.The dhr is no longer available in tuttlingen due to the age of the instrument (over 12 years old).The exact date of manufacture is unknown.Product development investigation was completed.A visual inspection, device history review (dhr), and drawing review were performed as part of this investigation.Replication of the complaint is not possible as the complaint could not be confirmed.The returned instrument was examined and the complaint condition was unable to be confirmed as the device was received without any observable residue.Any residue that was present likely was removed in the sterilization process prior to receipt.Relevant drawing for the returned instrument was reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of this device.As a pool of residue could not be identified on the returned instrument, the complaint condition was unable to be confirmed.No definitive root cause could be determined however the complaint condition is typically associated wear/tear and degradation of the handle material (phenolic le) as the result of repeated sterilization cycles.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: SCREWDRIVER FOR PINS
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6864430
• Report Number: 9680938-2017-10132
• Device Sequence Number: 108019
• Product Code: HXX
• UDI-Device Identifier: 10705034711102
• UDI-Public: (01)10705034711102(10)A70A15
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2017

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: U44-642-20
• Device Catalogue Number: U44-642-20
• Device Lot Number: A70A15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1