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

Catalog Number 296.766S

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 an unknown date the patient underwent for a procedure of fixation the bilateral sacral fracture with previous surgical intervention for total hip prosthesis utilizing a dps sacral bar implant with nuts and washers.Postoperatively, the patient presented hematoma and infection, reoperation was due to hematoma and infection.There was a known healing of fracture reported.Patient outcome is unknown.No further information is available.Concomitant device reported: unk - nuts (part# unknown; lot# unknown; quantity: unknown).Unk - washer (part# unknown; lot# unknown; quantity: unknown).This complaint involves five (5) devices.This report is for (1) 6.0mm threaded sacral bar 260mm.This report is 1 of 2 for (b)(4).

• Brand Name: 6.0MM THREADED SACRAL BAR 260MM
• Type of Device: PIN,FIXATION,THREADED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12563156
• MDR Text Key: 274297041
• Report Number: 8030965-2021-08256
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 07611819343283
• UDI-Public: (01)07611819343283
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K001720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 296.766S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - NUTS; UNK - PLATES: TRAUMA; UNK - SCREWS: TRAUMA; UNK - WASHERS
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR