MAUDE Adverse Event Report: SYNTHES ELMIRA 3.5MM TI LCP MEDL ANT CLAVICLE PLATE/8 HOLE/102MM-STERILE; PLATE,FIXATION,BONE

Catalog Number 04.112.042S

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

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 09/07/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information not available for reporting.(b)(4).Device not implanted or explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).(b)(4).Device history records review was conducted.The report indicates that: #(b)(4) ¿ (b)(6) 2016, dom: (b)(6) 2011, sterile: (b)(6) 2021.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of lcp medl ant clavicle plate was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.This order met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications at time of acceptance.No nonconforming reports were noted.The raw material met all dimensional and visual criteria at the time of release with no issues documented.If information was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that the reported plate was used during a mipo (minimally invasive percutaneous plate osteosynthesis) surgery on (b)(6) 2016.After the fixation, the surgeon checked the fractured section.Then he noticed that the fracture line had extended to the distal area.Because he thought further fixation was in need, he replaced it with a lcp lateral extension plate.Finally he completed the surgery.There was a surgical prolongation of 30 minutes.Patient is in his 50's.This complaint involves 1 part.Concomitant devices: (b)(4) this report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A product development investigation was performed.We have received the following parts for investigation: part 04.112.042s / #lot 6760629 / lcp anterior clavicle plate 3.5, 8 holes, l 102mm concomitant devices: part 412.106s / #lot 9641891 / lockscr ø3.5 self-tap l20 tan, part 412.106s / #lot 9608389 / lockscr ø3.5 self-tap l20 tan, part 412.109s / #lot 9610084 / lockscr ø3.5 self-tap l26 tan.Three locking screws ø3.5 self-tap were received in a used condition with signs of wear on the threads.The device history record was researched and no abnormal findings were identified.Manufacturing and inspection records indicated no problems with the lot in question.Considering that the implants did not affect the complaint, the parts were added as concomitant.Part 04.112.042s / lcp anterior clavicle plate was received in used condition with slight scratches on the surface and wear signs on the threads.The manufacturing document shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.The device met the specifications at the time of manufacturing and distribution in october 2011.Failure in material or production could not be detected.Based on the provided information we are not able to determine why the fracture line had extended to the distal area.The technique guide can be referenced to prevent such situations and details regarding ¿determine plate length and adapt plate.¿ based on our investigations a product related fault can be excluded.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 3.5MM TI LCP MEDL ANT CLAVICLE PLATE/8 HOLE/102MM-STERILE
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5977610
• MDR Text Key: 55615434
• Report Number: 3003506883-2016-10162
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Catalogue Number: 04.112.042S
• Device Lot Number: 6760629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2016
• Initial Date FDA Received: 09/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/18/2016; 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1X 412.106S, (LOCKSCR Ø3.5 SELF-TAP L20 TAN); 1X 412.106S, (LOCKSCR Ø3.5 SELF-TAP L20 TAN); 412.109S, (LOCKSCR Ø3.5 SELF-TAP L26 TAN)
• Patient Outcome(s): Required Intervention