MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SCREWDRIVER SHAFT T25 STRAIGHT TIP/6MM HXC; SCREWDRIVERS

Catalog Number	03.620.064
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient¿s identifier reported as (b)(6).Patient¿s date of birth/age and weight are unknown.Device is an instrument and is not implanted/explanted.Reporter¿s phone number is unknown.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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 a scheduled spine revision surgery on (b)(6) 2017, the screwdriver broke during the removal of the setscrew.Surgeon and nurse confirmed that all broken parts were removed.No broken parts left in the patient's body.Surgeon needed to remove the rod and insert few more screws during the scheduled hardware removal surgery.There was no patient consequence and no surgical delay.Concomitant device reported: screw (part# unknown, lot# unknown, quantity 1).This report is for one (1) screwdriver shaft.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Dhr review was completed.Part number: 03.620.064, lot number: 3804703, manufacturing location: (b)(4), release to warehouse date: 28 july 2011.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.Customer quality conducted an investigation of the returned device.Received condition: beside of the broken off stardrive t25 tip the screw driver shaft 03.620.064 is in visual good condition.The broken off portion is available for investigation.Conclusion: the microscopic visual investigation shows deformation and wear on the remaining stardrive t25 tip on the shaft as well as on the broken off portion of the stardrive t25 tip.Because of the damage the dimensions and features relevant to the complaint could not be checked anymore.The fracture face is homogeneous, which indicates material conformity and shows the typical view of a forced rupture.The device history review of the blank shaft 60014249 shows that during manufacturing a hardness test was performed with hardness tester no.4673-h with the result of 58.00 hrc.The result of the hardness test meets the specification 56 ¿ 60 hrc according to on drawing.The dhr review shows that the device met fully to our specifications at the time of manufacturing in july 2011.No manufacturing related issues that would have contributed to this complaint were found.The device was manufactured and distributed almost 7 years ago and was subject to frequent use.The exact root cause of this event cannot be determined but the most probable reason is mechanical overloading.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: SCREWDRIVER SHAFT T25 STRAIGHT TIP/6MM HXC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7189255
• Report Number: 8030965-2018-50340
• Device Sequence Number: 949228
• Product Code: HXX
• UDI-Device Identifier: 07611819941786
• UDI-Public: (01)07611819941786(10)3804703
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2017

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 Catalogue Number: 03.620.064
• Device Lot Number: 3804703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 01/15/2018
• Supplement Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1