MAUDE Adverse Event Report: SYNTHES GMBH 2.9MM TI MATRIXRIB LCKNG SCREW SELF-TAPPING/14MM; PLATE,FIXATION,BONE

Catalog Number 04.501.024.01

Device Problems Break (1069); Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 during an unknown procedure, cross threading of the 2.9mm matrixrib locking screw was observed after inserting the screw into the matrixrib locking plate.The affected screw and thread were removed.Fragments were generated and easily removed from the patient without additional intervention.This was confirmed by x-ray.There was no surgical delay.The procedure was successfully completed by placing a new screw.There was no patient consequence.Concomitant device reported: unknown matrixrib plate (part # unknown, lot # unknown, quantity 1).This report is for one (1) 2.9mm ti matrixrib lckng screw self-tapping/14mm.This is report 1 of 1 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, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Investigation summary picture review: narrative (portion of the thread has sheared off) could be confirmed from the provided picture.Part number could not be verified.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventive 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.

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: h3, h4, h6- the threads of the received screw are flattened (damaged) and the anodized layer disappeared.Furthermore, the scew recess show strong sings of use.A small thin metal chip (most probably of the screw) was also received.The received condition of the complaint agrees with the complaint description that the screw got cross threaded.Thus, the complaint is rated as confirmed.Based on the received information, we assume that the screw excessively interfered with the plate and got damaged.Insertion angle issues or not exactly following the surgical technique could have led to the mentioned cross threading.We can confirm the visible damages are not from any manufacturing non-conformity.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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/14MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10919658
• MDR Text Key: 218726340
• Report Number: 8030965-2020-09246
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819354111
• UDI-Public: (01)07611819354111
• 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,Followup,Followup
• Report Date: 11/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.501.024.01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 01/27/2021
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: MATRIXRIB.; UNK - PLATES: MATRIXRIB