MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM HEXAGONAL SCREWDRIVER SHAFT-6MM HXC; SCREWDRIVERS

Catalog Number	389.829
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted: part: 389.829; lot: l729695; manufacturing site: (b)(4).Release to warehouse date: 12.Jan.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was conducted.Visual inspection: upon visual inspection of the complaint device it can be seen that the hexagonal tip is slightly twisted as well some edges are deformed, these damage are from tighten.Document/specification review: drawings and revisions are in accordance to dhr of production lot l729695.All relevant features are defined on the used drawing revisions of dhr of production lot l729695.Dimensional inspection: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed.Summary: there is no particularize information what's happened to this article by customer, unfortunately we are not able to determine the exact reason for this occurrence, but we have to assume that excessive force led to this damage or/and that during the operation an application error may have taken place.To prevent such problems, it is necessary worn or damaged instruments to replace and/or to operate according to the technique guide.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that during anterior lumbar interbody fusion (alif) l4-l5 procedure on (b)(6) 2019, the hexagonal screwdriver from the anterior tension band (atb) plate system was not locking off and has no clear click sound when locking the screws.The procedure was successfully completed using another atb set.There was no surgical delay and no adverse consequence to the patient.  upon manufacturer's investigation of the received complaint device it can be seen that the hexagonal tip is slightly twisted as well some edges are deformed concomitant device/s reported: unknown screws (part # unknown, lot # unknown, quantity unknown), screwdriver (part # 287110550, lot # unknown, quantity 1)  this report is for one (1) 3.5mm hexagonal screwdriver shaft-6mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 3.5MM HEXAGONAL SCREWDRIVER SHAFT-6MM HXC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8875562
• Report Number: 8030965-2019-67040
• Device Sequence Number: 14051011
• Product Code: HXX
• UDI-Device Identifier: 07611819775985
• UDI-Public: (01)07611819775985
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 05/29/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 389.829
• Device Lot Number: L729695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1