MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.9MM TI MATRIXRIB LCKNG SCREW SELF-TAPPING/20MM; PLATE, FIXATION, BONE

Catalog Number 04.501.030.01S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994); Reaction (2414)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Patient's birth year reported as (b)(6).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.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 Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, a patient was treated with a matrixrib plate and screws.Initial procedure was completed successfully.On (b)(6) 2020, the patient returned to the hospital due to fever, pain and redness.The implants need to be removed due to infection.Explantation/part removal will not be performed.No further information provided.This report is for one (1) 2.9mm ti matrixrib lckng screw self-tapping/20mm.This is report 2 of 7 for (b)(4).

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.H3, h4, h6- 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 history lot part: 04.501.030.01s, lot: l345787, manufacturing site: mezzovico, release to warehouse date: 28.March 2017, expiry date: 01.March 2027.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 2.9MM TI MATRIXRIB LCKNG SCREW SELF-TAPPING/20MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10344619
• MDR Text Key: 201062954
• Report Number: 8030965-2020-05471
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819615250
• UDI-Public: (01)07611819615250
• Combination Product (y/n): N
• PMA/PMN Number: K161590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.501.030.01S
• Device Lot Number: L345787
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention