MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/35MM; SCREW,FIXATION,BONE

Model Number	206.035
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: patient weight was not provided for reporting.Date of event is unknown.(b)(4).The device was 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 (b)(4) reports an event as follows: it was reported that patient underwent osteosynthesis of proximal humerus with a 3.5mm locking compression plate (lcp) proximal humerus plate and seven (7) screws on (b)(6) 2017.Procedure was completed successfully.Post-operatively it was noted the plate was broken.It was also noted that patient bone has necrosis.Revision surgery was performed on (b)(6) 2017 without any issues.Implants were removed.Patient will receive unspecified additional treatment prior to implanting new material.This report is for one (1) 4.0mm cancellous bone screw fully threaded/35mm.(b)(4).
Additional Manufacturer Narrative
Device history records review was completed for part# 206.035, lot# l240034.Manufacturing location: (b)(4), release to warehouse date: dec 13, 2016.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product development investigation was completed.A device history record (dhr) review, device inspection, and x-ray review were performed as part of this investigation.The returned cancellous bone screw ø 4.0mm, l 35mm was visually checked and no damage could be detected.The review of the device history record revealed that this device was manufactured in december 2016 according to the specifications.The part conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformity specific to the part reported.The lot went through the required steps during the inspection at the time of manufacturing and the dhr records showed no issues concerning the material or material conditioning.The visual inspection of the cancellous bone screw did not show any abnormalities neither any defects could be found.Provided x-rays were reviewed.No issues with the screws were identified.Thus, the complaint condition for this device could not be confirmed or replicated.There is no indication that a design or manufacturing issue contributed to the complaint.No malfunctions were observed during the course of this investigation.As no malfunction was identified, no further investigation was performed.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: 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/35MM
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7209150
• Report Number: 8030965-2018-50525
• Device Sequence Number: 11018720
• Product Code: HWC
• UDI-Device Identifier: 10886982147325
• UDI-Public: (01)10886982147325(10)L240034
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K083213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 206.035
• Device Catalogue Number: 206.035
• Device Lot Number: L240034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 01/22/2018
• Supplement Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR