MAUDE Adverse Event Report: SYNTHES GMBH LCP(TM) DISTAL FEMUR PLATE 11 HOLES/276MM RIGHT-STERILE; PLATE, FIXATION, BONE

Catalog Number 222.256S

Device Problem Break (1069)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Hematoma (1884); Pain (1994)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

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

It was reported that on an unknown date, the patient fell while trying to stand up on his own which caused a diffuse pain and haematoma.It was discovered through x-ray that this caused a fracture of the distal third of the right femoral diaphysis with a third fragment.Corrective surgery to implant a new plate was performed on an unknown date.No further information was provided.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.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.Picture review: based on the provided x-ray and pictures it was confirmed that the lcp plate is cracked post-operative.One cracked lcp-distal femur plate, one broken locking screw together with six intact locking screws and two intact cortex screws were returned for investigation.Visual inspection: the lcp-distal femur plate is cracked as complained.The crack occurred in the shaft region at the eighth combi hole counted from proximal end.The plate presents only minor signs of use.Dimensional inspection: relevant dimensions ¿ plate thickness and width were checked and found to comply with the specifications.Document/specification review: relevant product drawings were reviewed during this investigation.This production lot 6l68934 was manufactured starting from the semifinished part# 60048825/ lot# 28p4944 (which corresponds to the supplier lot# pa10-01-022299-01) which was produced starting from the raw material heat n°.Pf41615.The certificate of raw material has been reviewed and met the specifications.The manufacturing record evaluation showed that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.The material and material properties of this lcp-distal femur plate were determined to be conforming at the time of manufacture.This plate is made of stainless steel (316l cdr / 1.4441) per iso 5832-1.Summary: the complaint condition is confirmed as the lcp-df plate was found cracked.The for the complaint relevant dimensions were checked as far as possible and found to be within specifications.This lot of 12 pieces was manufactured in february 2020 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.The correct material was used.A manufacturing related issue can be excluded, and we conclude that the cause of the crack is related to the patient¿s fall.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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: this mre review is for sterilization procedure only.Part: 222.256s, lot: 6l68934, manufacturing site: selzach , supplier: früh (b)(4), release to warehouse date: 12.February 2020, expiry date: 01.February 2030.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile part was manufactured in mezzovico , part: 222.256, lot: 34p8919, manufacturing site: mezzovico , release to warehouse date: 19 jan 2020.The involved lot has been blocked at final inspection for a thread issue, but after the evaluation all the items resulted conforming as documented on the dhr form.A manufacturing record evaluation was performed for the not sterile 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.

Event Description

Concomitant devices reported: cortscr ø4.5 self-tap l30 sst (part# 214.830s, lot# 6l97943, quantity# 1).Cortscr ø4.5 self-tap l34 sst (part# 214.834s, lot# l867775, quantity# 1).Lockscr ø5 self-tap l38 sst (part# 213.338s, lot# 54p5490, quantity# 2).Lockscr ø5 self-tap l60 sst (part# 213.360s, lot# 64p8962, quantity# 1).Lockscr ø5 self-tap l65 sst (part# 213.365s, lot# 64p1186, quantity# 1).Lockscr ø5 self-tap l70 sst (part# 213.370s, lot# 57p3309, quantity# 1).Lockscr ø5 self-tap l40 sst (part # 213.340s, lot # 67p2428, quantity 1).

• Brand Name: LCP(TM) DISTAL FEMUR PLATE 11 HOLES/276MM RIGHT-STERILE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10941614
• MDR Text Key: 219502128
• Report Number: 8030965-2020-09361
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819189133
• UDI-Public: (01)07611819189133
• Combination Product (y/n): N
• PMA/PMN Number: K062564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 222.256S
• Device Lot Number: 6L68934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Date Manufacturer Received: 01/04/2021
• Patient Sequence Number: 1
• Treatment: CORTSCR Ø4.5 SELF-TAP L30 SST; CORTSCR Ø4.5 SELF-TAP L34 SST; LOCKSCR Ø5 SELF-TAP L38 SST (QTY 2); LOCKSCR Ø5 SELF-TAP L40 SST; LOCKSCR Ø5 SELF-TAP L40 SST; LOCKSCR Ø5 SELF-TAP L60 SST; LOCKSCR Ø5 SELF-TAP L65 SST; LOCKSCR Ø5 SELF-TAP L70 SST; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention