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

Catalog Number	388.079
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age, date of birth, gender, and weight not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is synthes sales consultant.A review of the device history records has been requested.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 europe reports an event in (b)(6) as follows: it was reported that during an unknown procedure on an unknown date, two (2) hexagonal screwdriver shafts were defective.The two screwdrivers dusted one of the last screws that the surgeon was implanting.There was a surgical delay for about two (2) hours.Patient outcome is unknown.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity 1).This report is for one (1) 3.5mm hexagonal screwdriver shaft.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Date of event.Updated event description.Added therapy date.Reporter¿s name; 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
Further it was reported that during an unknown procedure on (b)(6) 2018, two (2) hexagonal screwdriver shafts were defective.Procedure was completed successfully.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for part number: 388.079, synthes lot number: l215740: manufacturing site: (b)(4), release to warehouse date: 29.November 2016: the device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Only top level of the device history record reviewed as sub-components are not lot tracked.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.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: 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: 7683574
• Report Number: 8030965-2018-54989
• Device Sequence Number: 18994066
• Product Code: HXX
• UDI-Device Identifier: 07611819826700
• UDI-Public: (01)07611819826700
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 06/15/2018

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: 388.079
• Device Lot Number: L215740
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 08/10/2018; 09/11/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 09/06/2018; 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(6) 2018