MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM; APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT

Model Number 241.901

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

Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Complainant device 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.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 the patient underwent revision of a plate and eight screws on (b)(6) 2017 due to malunion and nonunion.The 3.5mm locking compression plate (lcp) proximal humerus plate and screws were originally implanted on an unknown date.The procedure included implantation of multiloc humeral nail + ria bone graft harvest from left femur & application.The procedure was successfully completed with no delay.The patient outcome was as planned.This report is for one (1) 3.5mm lcp proximal humerus plate-standard 3h shaft/90mm.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

A device history record review was performed for the subject device lot no.: 9841460.Manufacturing location: (b)(4).Release to warehouse date: 02.Mar.2016.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product development investigation was performed for the subject device: a 3.5mm lcp proximal humerus plate (part 241.901 | lot 9841460 | quantity 1) was reported with the complaint category of ¿no reported product problem: adverse event: nrm.¿ however, the device was not returned for investigation; only an x-ray was provided.The provided x-rays in ¿(b)(4) x-ray 1 from sales consultant (b)(6) 2017,¿ ¿(b)46) x-ray 2 from sales consultant (b)(6) 2017,¿ ¿(b)(4) x-ray 3 from sales consultant (b)(6) 2017,¿ and ¿(b)(4) x-ray 4 from sales consultant (b)(6) 2017¿ were reviewed.The provided images show a plate with three (3) screws in the shaft of the plate and five (5) screws in the head of the plate.No defects or deficiencies in the devices were observed on the x-ray.As the complaint category for this device is ¿no reported product problem: adverse event: nrm¿ the condition is confirmed and consistent with the reported condition.Replication of the condition is not applicable for this complaint condition.As the physical device was not received no further dimensional or material testing could be completed and the device could not be inspected to the drawing specification.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The lot went through the required steps during the inspection at the time of manufacturing and the dhr records showed no issues concerning the material or material conditioning.In conclusion, a visual inspection via the provided x-ray was performed as part of this investigation.No defects of deficiencies in the device were observed on the x-ray.Thus, it is confirmed that no product problem was identified.No definitive root cause was able to be determined as circumstances surrounding the event are unknown.During the investigation no product issues were observed that may have contributed to the complaint condition.No new malfunctions were observed during the course of this investigation.Based on the information available, 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.

• Brand Name: 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM
• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BIO OBERDORF (CH); eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7080486
• MDR Text Key: 93682679
• Report Number: 8030965-2017-50268
• Device Sequence Number: 1
• Product Code: KTW
• UDI-Device Identifier: 10886982167620
• UDI-Public: (01)10886982167620(10)9841460
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 241.901
• Device Catalogue Number: 241.901
• Device Lot Number: 9841460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2018
• Date Device Manufactured: 03/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention