MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 12MM; SCREW, FIXATION, BONE

Catalog Number 04.211.012S

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

Additional device product code: hrs.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: this mre review is for sterilization procedure only part: 04.211.012s, lot: 6l21026, manufacturing site: (b)(4), supplier: (b)(6) release to warehouse date: 26.Sep 2019, expiry date: 01.Sep.2029, a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile 04.211.012 / 14l8269 was manufactured in us, (b)(4), manufacturing location: (b)(4), manufacturing date: 19-aug-2019, part number: 04.211.012, 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 12mm, lot number: 14l8269 (non-sterile), lot quantity: (b)(4).This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: pat number: 04.211.012.999, 2.8mm ti screw blank 12mm 02.7 variable angle w/sd8, lot number: 10l5319, lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, inspect warm head blank/inspect turn head and point, (b)(4) rev c met all inspection acceptance criteria.Part number: 23032, tialnbci2.78, lot number: h715566, lot quantity: (b)(4) lbs.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent an open reduction internal fixation surgery for the proximal ulna fracture with the screwdriver in question.During the surgery, the surgeon could not insert the locking screw into the bone completely because the head of the locking screws were getting worn-out.The torque limitation mechanism seemed not to be working properly.Both the surgeon and a supervising physician tried to insert very carefully, but the problem didn't improve.The surgery was completed with the screw inserted incompletely.It is unknown out of six screws which screw was inserted incompletely.The surgery was delayed by less than thirty (30) minutes.The surgeon commented that there is a possibility that either the connection of the screwdriver and the screw was incomplete or the torque limiting attachment was defective.The surgeon worries that the screw may come out because of the incomplete insertion.No further information is available.Concomitant device reported: unknown plate (part# unknown ,lot# unknown, quantity 1).This report is for one (1) 2.7mm ti va locking screw 12mm.This is report 5 of 7 for complaint (b)(4).

• Brand Name: 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 12MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9492437
• MDR Text Key: 178782732
• Report Number: 8030965-2019-71246
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819425217
• UDI-Public: (01)07611819425217
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.211.012S
• Device Lot Number: 6L21026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1