MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAILS-STER; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.005.428S

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.Additional product code: hwc.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary: reviewing dhr shows that the affected lot was released after complete final inspection with no detected issues regarding manufacturing procedure.This screw was released in faultless condition.For details, please see appropriate section device history.Based on the complaint description, without material we are not able to perform any investigation.Device history lot: please note, this dhr review is for sterilization procedure only: part no.: 04.005.428s.Lot no.: 8670708.(b)(4).Supplier: (b)(4).Release to warehouse date: 20.Oct.2013.Expiry date: 01.Oct.2023.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Non-sterile 04.005.428/8623882 was manufactured in (b)(4).Release to warehouse date: 17.Sep.2013.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product was not returned.Based on the information available, 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.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that the orif was applied to proximal humeral fractures on (b)(6) 2018.While the surgeon was inserting locking screw in question into a multiloc humeral nail, it was found that there were metal fragments around the locking screw.The metal fragments were same color as the locking screw.Because it was not specified where the fragments came from, the surgeon stopped using the locking screw in question, cleaned the screw hole area, closed the incision, and completed the rest of the surgery within a 30-minute delay.The patient has been in stable condition since the surgery.This complaint involves one part.This report is 1 of 1 for (b)(4).

• Brand Name: 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAILS-STER
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• 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: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7430344
• MDR Text Key: 105545344
• Report Number: 8030965-2018-53102
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819789555
• UDI-Public: (01)07611819789555
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Catalogue Number: 04.005.428S
• Device Lot Number: 8670708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Date Device Manufactured: 10/20/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1