MAUDE Adverse Event Report: SYNTHES GMBH 6.5MM CANCELLOUS BONE SCREW WITH 4.0MM CORE DIA/100MM; SCREW, FIXATION, BONE

Model Number	218.017
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 or Problem Description
It was reported that on (b)(6) 2022, the surgeon planned to remove a large fragment reconstruction plate and screws from a previous shoulder fusion in order to perform an im nailing of a humerus.This hardware was successfully removed and a multiloc humeral nail was used to pass through the shoulder fusion and successfully fixate the fracture.There were no allegations against the plate and screw construct.No further information is available.This report involves one 6.5mm cancellous bone screw with 4.0mm core dia/100mm.This is report 9 of 9 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a1: patent identifier: mrn:(b)(6).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: 6.5MM CANCELLOUS BONE SCREW WITH 4.0MM CORE DIA/100MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15668464
• Report Number: 8030965-2022-08889
• Device Sequence Number: 6421356
• Product Code: HWC
• UDI-Device Identifier: 10886982155849
• UDI-Public: 10886982155849
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 218.017
• Device Catalogue Number: 218.017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 10/29/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 11/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6.5 CANCELLOUS SCREW 4.0 CORE DIA/100; RECOPL 4.5 STRAIGHT 10HO L157 SST; UNK - SCREWS: 4.5 MM CORTEX; UNK - SCREWS: 4.5 MM CORTEX; UNK - SCREWS: 4.5 MM CORTEX; UNK - SCREWS: 4.5 MM CORTEX; UNK - SCREWS: 4.5 MM CORTEX; UNK - SCREWS: 4.5 MM CORTEX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Unknown
• Patient Weight: 54 KG