MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 50MM; APPLIANCE, FIXATION, NAIL

Catalog Number 413.350S

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

Patient Problems Paralysis (1997); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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.A device history record review has been requested.(b)(4).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 (b)(6) reports an event as follows: it was reported that the patient underwent a high tibial osteotomy due to gonarthrosis on (b)(6) 2018.During the procedure, a k-wire was inserted from the medial side of the tibia.The bone was cut with a sagittal saw.Five (5) slat chisels were inserted into the affected site.A tomofix anatomical plate was used to fix the affected site.On (b)(6) 2018, patient had compartment syndrome which prompted an urgent relief incision.The surgeon thinks that the event was due to the damage of the medial inferior artery of the knee during the initial surgery due to the bone saw or a muscle hook.The patient experienced slight paralysis associated with compartment syndrome.Patient remains in the hospital with signs of compartment syndrome on the lateral posterior side.The patient will be monitored for two weeks.After muscular atrophy occurs, additional treatment will be performed.Concomitant device: k-wire (part: unknown, lot: unknown, quantity: 1).This report is for a 5.0mm titanium (ti) locking head screw 50mm.This is report 5 of 10 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.A device history record (dhr) review was conducted: part: 413.350s, lot: l776983 , manufacturing site: grenchen, supplier: (b)(4), release to warehouse date: 16.Feb.2018 , expiry date: 01.Feb.2028.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.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.Additional narrative: b5.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

It is unknown if the screws were explanted or if they are still implanted.

• Brand Name: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 50MM
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7957446
• MDR Text Key: 123438107
• Report Number: 8030965-2018-57216
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819268906
• UDI-Public: (01)07611819268906
• Combination Product (y/n): N
• PMA/PMN Number: K023941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 413.350S
• Device Lot Number: L776983
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 76