MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SCRDRIVER T25 LONG W/T-HANDLE F/MATRIX; SCREWDRIVERS

Catalog Number	03.632.074
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Date of event is unknown.Device is an instrument and is not implanted/explanted.Address and other contact information is unknown.A device history record review was requested.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product 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.
Event or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the screwdriver was in poor quality.The threaded tip of the device is damaged.There was no patient harm and the surgery was successfully completed with no surgical delay as they had two devices on the set.The tip of the screwdriver is stripped.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Reporter¿s phone number is unknown.A device history record (dhr) review was conducted for part number: 03.632.074, synthes lot number: 9824265: release to warehouse date: 19-oct-2015, manufacturing site: synthes (b)(4): 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 this product, and any subcomponents, which would contribute to this complaint condition.A product investigation was conducted.The t25 stardrive screwdriver (part: 03.632.074, lot: 9824265, mfg: 19-oct-2015) was inspected at us customer quality (cq).Upon visual inspection, it was observed that the distal tip of the t25 stardrive screwdriver¿s shaft was worn and rounded/stripped.Also, the t25 stardrive screwdriver shows signs of minimal wear for its 2-year lifetime.No new malfunctions have been identified.The received condition agrees with the complaint description.Dimensional inspection: dimensional analysis was not performed due to post-manufacture damage of the small hexagonal pelvic screwdriver.Document/specification review: relevant drawing(s) was reviewed; no design or manufacturing defect or deficiency was observed during the investigation conclusion: the complaint condition is confirmed.While no definitive root cause could be determined, it is possible that the device encountered unintended forces (such as being dropped, struck off-axis or damaged during usage or handling or sterile processing).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: SCRDRIVER T25 LONG W/T-HANDLE F/MATRIX
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7625721
• Report Number: 8030965-2018-54492
• Device Sequence Number: 16489661
• Product Code: HXX
• UDI-Device Identifier: 07611819377301
• UDI-Public: (01)07611819377301
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2018

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: 03.632.074
• Device Lot Number: 9824265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1