MAUDE Adverse Event Report: SYNTHES OBERDORF LONG SCREWDRIVER WITH T-HANDLEFOR CLICK'X® LOCKING CAP; SCREWDRIVERS

Model Number	388.365
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.No patient involvement reported.Device is an instrument and is not implanted/explanted.Reporter's phone number: (b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: part #: 388.365, lot#: 1223613.Dhr not available as device is older than 13 years.Referring to (filing and archiving of specification documents) version ai valid until august 2014 the manufacturing documents for instruments had to be stored for 10 years.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 the instruments needed to be repaired, the tip of the fork of the long screwdriver with t-handler for click x locking cap is slightly bent and will not enable interfacing or self-retention of a locking set screw/cap for insertion; the cone tip of the remobilizer of the extraction pliers for click x is broken from the weld and not reliable for surgery - it still slides onto the 2-piece remobilizer, but is unfit for use; the tips of the driver of two screw inserters t8 self-retaining/qc do not self-retain screws.This was discovered during routine inspection.There is no procedure or patient involvement.This complaint involves 1 device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Customer quality conducted an investigation of the returned device.The returned screwdriver (388.365, 1223613) was received with its distal tongs bent, which confirmed its complaint condition and made its replication inapplicable.As part of this investigation a visual inspection, drawing review, and root cause analysis were performed.The dhr for the returned screwdriver (388.365, 1223613) was not available since the device is older than 13 years, but drawing was reviewed.All relevant drawings were reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.During the investigation no unidentified product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the available information it is not possible to determine a definitive root cause for the reported complaint conditions.According to its associated technique guide, the returned screwdriver is intended to have its tongs firmly fit into the slots of the locking cap during use.It is possible that if the screwdriver was used without its tongs being firmly fit into the slots of the locking cap, it could have contributed to its complaint condition.A dimensional inspection was inapplicable for the screwdriver tip due to post market damage.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: LONG SCREWDRIVER WITH T-HANDLEFOR CLICK'X® LOCKING CAP
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• MDR Report Key: 7032941
• Report Number: 8030965-2017-16237
• Device Sequence Number: 1770060
• Product Code: HXX
• UDI-Device Identifier: 10705034772615
• UDI-Public: (01)10705034772615(10)1223613
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/23/2017

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: 388.365
• Device Catalogue Number: 388.365
• Device Lot Number: 1223613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1