MAUDE Adverse Event Report: SYNTHES GMBH 6.0MM THREADED SACRAL BAR 260MM; PIN, FIXATION, THREADED

Model Number	296.766
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Type of Reportable Event	Serious Injury
Additional Manufacturer 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
Device report from (b)(6) reports an event as follows: it was reported that the patient underwent a procedure on an unknown date for fixation of a unilateral sacral fracture, utilizing a sacral bar implant 260 mm with nuts and washers (stainless steel).Postoperatively, the patient presented hematoma and bleeding anemia, reoperation was due to hematoma.Healing was not assessable because of early mortality.Patient outcome is unknown.No further information is available.This report is for a 6.0mm threaded sacral bar 260mm.This is report 1 of 1 for (b)(4).

• Brand Name: 6.0MM THREADED SACRAL BAR 260MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12563292
• Report Number: 8030965-2021-08258
• Device Sequence Number: 1415011
• Product Code: JDW
• UDI-Device Identifier: 10886982182487
• UDI-Public: (01)10886982182487
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K001720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2021

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: 296.766
• Device Catalogue Number: 296.766S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 10/01/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NUTS; UNK - WASHERS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR