MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: TIBIA; PLATE,FIXATION,BONE

Device Problem Device-Device Incompatibility (2919)

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

Event Date 03/05/2021

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown plates: tibia/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.Investigation summary picture review: based on the provided picture the damage of the screw head could be confirmed.It looks like as if the wall of the screw recess has sheared off.Damage to the plate could not be verified without having the material back for investigation.Although the provided picture does not allow for any determination of the root cause it should be noted that multiple factors can lead to technical difficulties during removal of lcp plates with locking screws.These factors include, but are not limited to: wrong torque or angulation of the screw during insertion leading to cold-welding between the plate and the screw thread, or proteins which are forming a bond between the plate and screw thread.Some of these factors are patient specific factors or they depend on the proper care of the surgeon, and can thus not be investigated nor controlled by depuy synthes.Part and lot# of the involved plate was not provided and product was not returned, therefore no further investigation possible.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent surgery to have the tibial platform plate removed.The 3.5mm ti locking screw threads peeled and were unable to be removed.The surgeon had to damage the plate in order to remove the screw.There was a surgical delay of about one (1) hour.The patient outcome was stable.Concomitant devices reported: unknown screws (part # unknown, lot # unknown, quantity # unknown).This report is for one (1) unk - plates: tibia.This is report 2 of 2 for (b)(4).

Event Description

The bone fracture was healed and it is a common practice in mainland china to remove the implants.

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.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: UNK - PLATES: TIBIA
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11608396
• MDR Text Key: 280451479
• Report Number: 8030965-2021-02550
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2021
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø3.5 SELF-TAP L30 TAN